{"success":true,"data":{"pressRelease":{"id":"171959","rtpr_id":"nPn6bwDQba-20261018","ticker":"LLY","exchange":"NYSE","all_tickers":["LLY"],"title":"Lilly to showcase advances across its oncology pipeline at the 2026 European Society for Medical Oncology (ESMO) Congress","author":"PR Newswire","published_at":"2026-10-18T22:05:00.022Z","article_body":"Lilly to showcase advances across its oncology pipeline at the 2026 European Society for Medical Oncology (ESMO) Congress\nPR Newswire\n\nINDIANAPOLIS, Oct. 18, 2026\n\nFirst Phase 1 data for sofetabart mipitecan, Lilly's investigational\nFRα-targeting ADC, in platinum-sensitive ovarian cancer to be featured in a\nrapid oral presentation\n\nUpdated first-line data for olomorasib, an investigational therapy targeting\nKRAS G12C-mutant NSCLC, to be featured in a rapid oral presentation\n\nUpdated Phase 3 data for selpercatinib versus cabozantinib or vandetanib in\nadvanced, kinase inhibitor-naïve, RET-mutant MTC to be shared in a proffered\npaper\n\nINDIANAPOLIS, Oct. 18, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)\ntoday announced that new data from across its oncology portfolio will be\npresented at the European Society for Medical Oncology\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=277139152&u=https%3A%2F%2Fwww.esmo.org%2Fmeeting-calendar%2Fesmo-congress-2026&a=European+Society+for+Medical+Oncology)\n (ESMO) Congress, taking place October 23–27 in Madrid, Spain. Highlights\ninclude new Phase 1 data in platinum-sensitive ovarian cancer (PSOC) for\nsofetabart mipitecan (Sofe-M), Lilly's investigational FRα-targeting\nantibody-drug conjugate (ADC), in combination with bevacizumab, along with\nupdated findings for olomorasib, Retevmo (selpercatinib), and Verzenio\n(abemaciclib) in lung, thyroid, and breast cancers, respectively.\n\nKey Presentation Highlights:\n\nSofetabart mipitecan (Sofe-M; FRα-targeting ADC): A rapid oral presentation\non first Phase 1 data for sofetabart mipitecan plus bevacizumab in patients\nwith PSOC. These data support the ongoing Phase 3 clinical trial of Sofe-M in\nPSOC.\n\nOlomorasib (investigational KRAS G12C inhibitor):\nA rapid oral presentation on an updated integrated analysis from the Phase 1/2\nLOXO-RAS-20001 trial and the safety lead-in portion of the Phase 3 SUNRAY-01\ntrial, assessing olomorasib in combination with chemoimmunotherapy\n(pembrolizumab, pemetrexed, and platinum) as potential first-line treatments\nfor patients with advanced/metastatic KRAS G12C-mutant non-small cell lung\ncancer (NSCLC). These data support the ongoing Phase 3 clinical trial of\nolomorasib in first-line KRAS G12C-mutant lung cancer.\n\nRetevmo (selpercatinib; RET kinase inhibitor): A proffered paper presentation\non updated results from the Phase 3 LIBRETTO-531 study\nof selpercatinib versus cabozantinib or vandetanib (C/V) in advanced,\nkinase inhibitor-naïve, RET-mutant medullary thyroid cancer (MTC). These data\nhave supported global approvals of Retevmo in this treatment setting.\n\nVerzenio (abemaciclib; CDK4/6 inhibitor): A rapid oral presentation on\noverall survival data from the Phase 3 postMONARCH trial of abemaciclib plus\nfulvestrant in HR-positive, HER2-negative advanced breast cancer following\nprogression on a prior CDK4/6 inhibitor and endocrine therapy. These data\nsupport the abemaciclib plus imlunestrant results in the EMBER-3 trial and add\nto the evidence-based practice of switching endocrine therapy and CDK4/6\ninhibitor at progression in metastatic breast cancer.\n\n\"Lilly's presentations at ESMO reflect both the breadth of our oncology\nportfolio and the focus behind it: following compelling science wherever it\nhas the potential to change care,\" said Jacob Van Naarden, executive vice\npresident and president of Lilly Oncology. \"We're especially encouraged by the\ndata we're sharing for sofetabart mipitecan in platinum-sensitive ovarian\ncancer, which build on what we've seen with this medicine in\nplatinum-resistant disease and mark a critical step forward as we advance the\nongoing Phase 3 FRAmework-01 study across both settings. Our updated\nfirst-line data for olomorasib in KRAS G12C-mutant lung cancer are very\npromising, with clinical activity and a safety profile consistent with earlier\nfindings, which reinforce the importance of targeted therapy for patients from\nthe outset of their treatment journey. Alongside new data in thyroid and\nbreast cancers, these presentations represent meaningful momentum toward\nimproving care for people with cancer.\"\n\nA full list of abstract titles and viewing details are listed below:\n Abstract Title                              Author           Presentation      Session Title       Session Date/Time\n                                                              Type/#\n(CET)\n Sofe-M (sofetabart mipitecan; investigational ADC targeting FRα):\n Model-informed Phase 3 dose                 Jean-            Poster            Poster display      Friday, October 23\n selection for antibody-drug conjugate       Sebastien        #1016P            session\n15:15-16:00\n (ADC) sofetabart mipitecan (Sofe-M):        Frenel\n First prospective application of a\n clinical utility index (CUI)\n Efficacy and safety                         Chrisann Kyi     Rapid oral        Rapid oral 2:       Saturday, October 24\n of sofetabart mipitecan (Sofe-M), a                          #1246RO           Gynecological\n8:30-10:00\n folate receptor alpha (FRα) targeting                                          cancers\n antibody drug conjugate (ADC), plus\n bevacizumab in recurrent platinum\n sensitive ovarian cancer (PSOC)\n Sofetabart mipitecan (Sofe-M) in            Ana Oaknin       Poster            Poster display      Monday, October 26\n patients ≥65 y with platinum-resistant                       #1288P            session\n12:00-12:45\n and -sensitive ovarian cancer\n (PROC/PSOC) from the first-in-human\n phase 1 study\n Olomorasib (investigational KRAS G12C inhibitor)\n First-line (1L) olomorasib +                Marcelo V.       Rapid oral        Rapid oral 2:       Sunday,\n chemoimmunotherapy (Chemo-IO) in            Negrao           #2652RO           NSCLC, metastatic\nOctober 25\n KRAS G12C-mutant NSCLC: Updated\n8:30-10:00\n results from the LOXO-RAS-20001 and\n SUNRAY-01 trials\n First-line (1L) olomorasib +                Melissa L.       Poster            Poster display      Monday, October 26\n pembrolizumab in KRAS G12C-mutant           Johnson          #2683P            session\n12:00-12:45\n NSCLC: Updated results from LOXO-\n RAS-20001 and SUNRAY-01\n Retevmo (selpercatinib; RET kinase inhibitor)\n Updated results of randomized Phase         Jaume            Proffered paper   Proffered paper:    Monday, October 26\n 3 study of selpercatinib vs                 Capdevila        #4208O            NETs and\n10:15-11:45\n cabozantinib or vandetanib (C/V) in                                            endocrine tumors\n advanced, kinase inhibitor-naïve, RET-\n mutant medullary thyroid cancer\n (MTC)\n Verzenio (abemaciclib; CDK4/6 inhibitor)\n Association of p27 V109G SNP zygosity       Miguel           Poster            Poster display      Friday, October 23\n with outcomes                               Quintela-        #4498P            session\n15:15-16:00\n and abemaciclib treatment effect in         Fandino\n HR+, HER2– high-risk early breast\n cancer: results from monarchE\n Overall survival from the Phase             Kevin Kalinsky   Rapid oral        Rapid oral 1:       Saturday, October 24\n 3 postMONARCH trial of abemaciclib +                         #1RO              Breast cancer,\n10:15-11:45\n fulvestrant vs placebo + fulvestrant for                                       advanced stage\n HR+, HER2– advanced breast cancer\n following progression on a prior\n CDK4/6 inhibitor + endocrine therapy\n Three-month persistence and                 Isabel Blancas   ePoster           ePoster session     Friday, October 23\n adherence to adjuvant abemaciclib in        López-Barajas    #1933eP\n8:00\n high-risk HR+, HER2– early breast\n cancer: real world data from ABSIDE-S\n Treatment persistence and clinical          Hitomi Sakai     ePoster           ePoster session     Friday, October 23\n characteristics in patients with HR+,                        #615eP\n8:00\n HER2–, high-risk early breast cancer\n (EBC) treated with abemaciclib: A\n multi-country real-world study\n\nFor more information on Lilly's oncology pipeline, click here\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=2508125402&u=https%3A%2F%2Fwww.lillyoncologypipeline.com%2F%3Fgad_source%3D1%26gbraid%3D0AAAAA9Rru3oHs3Sy4g3vfexgNREGpgGpf%26gclid%3DCjwKCAjwvr--BhB5EiwAd5YbXq2ma8vcD6tpqZe5QErTeWllvIlp7wr7QAoGNMOl8fnCUoDfZ1ONeRoCtQgQAvD_BwE&a=here)\n.\n\nAbout Sofetabart Mipitecan\nSofetabart mipitecan (Sofe-M; LY4170156) is composed of an Fc-silent, folate\nreceptor alpha (FRα) specific humanized monoclonal antibody linked to\nexatecan, a topoisomerase I inhibitor, via a proprietary cleavable\npolysarcosine linker (PSARlink). Sofe-M was designed to target FRα across\nall expression levels with an improved therapeutic index. FRα is a\ncell-surface glycoprotein encoded by the gene FOLR1 that binds to the\nessential nutrients folic acid and reduced folates, bringing them into cells\nto facilitate cell division and growth.(1,2) FRα is overexpressed in many\nsolid tumors such as ovarian and endometrial cancers.(1,3,4 )Sofe-M has\nreceived Breakthrough Therapy Designation from the U.S. Food and Drug\nAdministration for platinum-resistant ovarian cancer (PROC) and is currently\nbeing evaluated in the Phase 3 FRAmework-01 trial. The study is being\nconducted in partnership with the European Network for Gynaecological\nOncological Trial groups (ENGOT – lead groups GINECO/NOGGO e.V.), the GOG\nFoundation (GOG), and the Asia-Pacific Gynecologic Oncology Trials Group\n(APGOT).\n\nAbout Olomorasib\nOlomorasib (LY3537982) is an investigational, oral, potent, and highly\nselective second-generation inhibitor of the KRAS G12C protein. KRAS is the\nmost common oncogene across all tumor types, and KRAS G12C mutations occur in\n13% of patients with non-small cell lung cancer (NSCLC), and 1–3% of\npatients with other solid tumors.(5 )Olomorasib is a highly potent covalent\ninhibitor with potential for greater than 90% target occupancy, which may\nallow for safer combinations with less toxicity.(6)\n\nOlomorasib is currently being studied in KRAS G12C-mutant cancers in\ncombination with pembrolizumab with or without chemotherapy for first-line\ntreatment of advanced NSCLC, in combination with immunotherapy for the\ntreatment of resected and unresectable NSCLC, and as monotherapy and in\ncombinations in other advanced solid tumors (NCT06119581, NCT06890598, and\nNCT04956640).\n\nAbout Retevmo\nRetevmo (selpercatinib, formerly known as LOXO-292)\n(pronounced reh-TEHV-moh) is a highly selective and potent\nRET kinase inhibitor with central nervous system (CNS)\nactivity. Retevmo may affect both tumor cells and healthy cells, which can\nresult in side effects. RET-driver alterations are predominantly mutually\nexclusive from other oncogenic drivers. Retevmo is a U.S. FDA-approved\noral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or\n≥50 kg, respectively), taken twice daily until disease progression or\nunacceptable toxicity.(7)\n\nINDICATIONS FOR RETEVMO (selpercatinib)\nRETEVMO is a kinase inhibitor indicated for the treatment of:\n\n * Adult and pediatric patients 2 years of age and older with advanced or\nmetastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by\nan FDA-approved test, who require systemic therapy\nIMPORTANT SAFETY INFORMATION FOR RETEVMO (selpercatinib)\n\nHepatotoxicity: Serious hepatic adverse reactions occurred in 4.6% of patients\ntreated with Retevmo. Increased aspartate aminotransferase (AST) occurred in\n62% of patients, including Grade 3 or 4 events in 11% and increased alanine\naminotransferase (ALT) occurred in 58% of patients, including Grade 3 or 4\nevents in 13%. Monitor ALT and AST prior to initiating Retevmo, every 2 weeks\nduring the first 3 months, then monthly thereafter and as clinically\nindicated. Withhold, reduce dose, or permanently discontinue Retevmo based on\nseverity.\n\nSevere, life-threatening, and fatal interstitial lung disease\n(ILD)/pneumonitis can occur in patients treated with Retevmo. ILD/pneumonitis\noccurred in 3% of patients who received Retevmo, including 0.3% with Grade 3\nor 4 events, and 0.2% with fatal reactions. Monitor for pulmonary symptoms\nindicative of ILD/pneumonitis. Withhold Retevmo and promptly investigate for\nILD in any patient who presents with acute or worsening of respiratory\nsymptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever).\nWithhold, reduce dose, or permanently discontinue Retevmo based on severity of\nconfirmed ILD.\n\nHypertension occurred in 43% of patients, including Grade 3 hypertension in\n20% and Grade 4 in one (0.1%) patient. Overall, 6.4% had their dose\ninterrupted, 1.5% had their dose reduced, and 0.2% discontinued Retevmo for\nhypertension. Treatment-emergent hypertension was most commonly managed with\nanti-hypertension medications. Do not initiate Retevmo in patients with\nuncontrolled hypertension. Optimize blood pressure prior to initiating\nRetevmo. Monitor blood pressure after 1 week, at least monthly thereafter, and\nas clinically indicated. Initiate or adjust anti-hypertensive therapy as\nappropriate. Withhold, reduce dose, or permanently discontinue Retevmo based\non severity.\n\nRetevmo can cause concentration-dependent QT interval prolongation. An\nincrease in QTcF interval to >500 ms was measured in 8% of patients and an\nincrease in the QTcF interval of at least 60 ms over baseline was measured in\n22% of patients. Retevmo has not been studied in patients with clinically\nsignificant active cardiovascular disease or recent myocardial infarction.\nMonitor patients who are at significant risk of developing QTc prolongation,\nincluding patients with known long QT syndromes, clinically significant\nbradyarrhythmias, and severe or uncontrolled heart failure. Assess QT\ninterval, electrolytes, and thyroid-stimulating hormone (TSH) at baseline and\nperiodically during treatment, adjusting frequency based upon risk factors\nincluding diarrhea.\n\nCorrect hypokalemia, hypomagnesemia, and hypocalcemia prior to initiating\nRetevmo and during treatment. Monitor the QT interval more frequently when\nRetevmo is concomitantly administered with strong and moderate CYP3A\ninhibitors or drugs known to prolong QTc interval. Withhold and dose reduce or\npermanently discontinue Retevmo based on the severity.\n\nSerious, including fatal, hemorrhagic events can occur with Retevmo. Grade\n≥3 hemorrhagic events occurred in 4.3% of patients treated with Retevmo\nincluding 4 (0.5%) patients with fatal hemorrhagic events, including cerebral\nhemorrhage (n=2), tracheostomy site hemorrhage and hemoptysis (1 each).\nPermanently discontinue Retevmo in patients with severe or life-threatening\nhemorrhage.\n\nRetevmo can cause hypersensitivity, including severe skin reactions such as\nStevens-Johnson Syndrome. All grade hypersensitivity occurred in 6% of\npatients receiving Retevmo, including Grade 3 in 2%. The median time to onset\nwas 1.9 weeks (range: 5 days to 6.5 years). Signs and symptoms of\nhypersensitivity included fever, rash and arthralgias or myalgias with\nconcurrent decreased platelets or transaminitis. Stevens-Johnson Syndrome has\nbeen observed in the post-marketing setting. Discontinue Retevmo in patients\nwith Stevens-Johnson Syndrome. If hypersensitivity occurs, withhold Retevmo\nand begin corticosteroids at a dose of 1 mg/kg prednisone (or equivalent).\nUpon resolution of the event, resume Retevmo at a reduced dose and increase\nthe dose of Retevmo by 1 dose level each week as tolerated until reaching the\ndose taken prior to onset of hypersensitivity. Continue steroids until patient\nreaches target dose and then taper. Permanently discontinue Retevmo for\nrecurrent hypersensitivity.\n\nTumor lysis syndrome (TLS) occurred in 0.9% of patients with medullary thyroid\ncarcinoma and 0.3% of patients with non-small cell lung cancer receiving\nRetevmo. Patients may be at risk of TLS if they have rapidly growing tumors, a\nhigh tumor burden, renal dysfunction, or dehydration. Closely monitor patients\nat risk, consider appropriate prophylaxis including hydration, and treat as\nclinically indicated.\n\nImpaired wound healing can occur in patients who receive drugs that inhibit\nthe vascular endothelial growth factor (VEGF) signaling pathway. Therefore,\nRetevmo has the potential to adversely affect wound healing. Withhold Retevmo\nfor at least 7 days prior to elective surgery. Do not administer for at least\n2 weeks following major surgery and until adequate wound healing. The safety\nof resumption of Retevmo after resolution of wound healing complications has\nnot been established.\n\nRetevmo can cause hypothyroidism. Hypothyroidism occurred in 15% of patients\ntreated with Retevmo; all reactions were Grade 1 or 2. Hypothyroidism occurred\nin 15% of patients (59/390) with thyroid cancer and 14% of patients (65/467)\nwith other solid tumors including NSCLC. Monitor thyroid function before\ntreatment with Retevmo and periodically during treatment. Treat with thyroid\nhormone replacement as clinically indicated. Withhold Retevmo until clinically\nstable or permanently discontinue Retevmo based on severity.\n\nBased on data from animal reproduction studies and its mechanism of action,\nRetevmo can cause fetal harm when administered to a pregnant woman.\nAdministration of selpercatinib to pregnant rats during organogenesis at\nmaternal exposures that were approximately equal to those observed at the\nrecommended human dose of 160 mg twice daily resulted in embryolethality and\nmalformations. Advise pregnant women and females of reproductive potential of\nthe potential risk to a fetus. Advise females of reproductive potential and\nmales with female partners of reproductive potential to use effective\ncontraception during treatment with Retevmo and for 1 week after the last\ndose. There are no data on the presence of selpercatinib or its metabolites in\nhuman milk or on their effects on the breastfed child or on milk production.\nBecause of the potential for serious adverse reactions in breastfed children,\nadvise women not to breastfeed during treatment with Retevmo and for 1 week\nafter the last dose.\n\nSlipped capital femoral epiphysis/slipped upper femoral epiphysis in pediatric\npatients (SCFE/SUFE) occurred in 1 adolescent (2.8% of 36 patients) receiving\nRetevmo in LIBRETTO-121 and 1 adolescent patient (0.5% of 193 patients)\nreceiving Retevmo in LIBRETTO-531. Monitor patients for symptoms indicative of\nSCFE/SUFE and treat as medically and surgically appropriate.\n\nSevere adverse reactions (Grade 3-4) occurring in ≥20% of patients who\nreceived Retevmo in LIBRETTO-001 were hypertension (20%), diarrhea (6.2%),\nprolonged QT interval (5%), fatigue (4.7%), musculoskeletal pain (4.1%),\ndyspnea (4.1%), hemorrhage (3.9%), abdominal pain (3.5%), vomiting (2.9%),\nurinary tract infection (2.2%), nausea (1.9%), headache (1.8%), edema (1.3%),\ndecreased appetite (0.9%), constipation (0.8%), rash (0.8%), and dizziness\n(0.5%).\n\nSevere adverse reactions (Grade 3-4) occurring in ≥15% of patients who\nreceived Retevmo in LIBRETTO-121 were increased weight (11%), vomiting (8%),\nconstipation (6%), diarrhea (2.8%), nausea (2.8%), upper respiratory tract\ninfection (2.8%), and urinary tract infection (2.8%).\n\nSevere adverse reactions (Grade 3-4) occurring in ≥15% of patients who\nreceived Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431\nwere hypertension (20% vs 3.1%), electrocardiogram QT prolonged (9% vs 0%),\nfatigue (3.2% vs 5%), edema (2.5% vs 0%), rash (1.9% vs 1.0%), diarrhea (1.3%\nvs 2.0%), abdominal pain (0.6% vs 2.0%), pyrexia (0.6% vs 0%), COVID19\ninfection (0.6% vs 0%), constipation (0% vs 1.0%), nausea (0% vs 1.0%),\nvomiting (0% vs 1.0%), and decreased appetite (0% vs 2.0%).\n\nSevere adverse reactions (Grade 3-4) occurring in ≥10% of patients who\nreceived Retevmo in LIBRETTO-531 were (Retevmo vs cabozantinib / vandetanib)\nhypertension (19% vs 18%), electrocardiogram QT prolonged (4.7% vs 2.1%),\nfatigue (4.1% vs 9%), diarrhea (3.1% vs 8%), rash (1.6% vs 4.1%), pyrexia\n(1.0% vs 0%), nausea (1.0% vs 5%), dry mouth (0.5% vs 1.0%), abdominal pain\n(0.5% vs 2.1%), stomatitis (0.5% vs 13%), headache (0.5% vs 0%), and decreased\nappetite (0.5% vs 5%).\n\nSerious adverse reactions occurred in 58% of patients who received Retevmo in\nLIBRETTO-001. The most frequently reported serious adverse reactions (in ≥2%\nof patients) were pneumonia, hemorrhage, abdominal pain, dyspnea, pleural\neffusion, sepsis, musculoskeletal pain, hyponatremia, vomiting, diarrhea, and\nincreased blood creatinine. Fatal adverse reactions occurred in 3% of patients\nin LIBRETTO-001; fatal adverse reactions included sepsis (n=6), respiratory\nfailure (n=5), hemorrhage (n=4), pneumonia (n=4), cardiac arrest (n=3),\npneumonitis (n=2), cardiac failure (n=2), sudden death (n=1), cerebral\ninfarction (n=1), and dyspnea (n=1).\n\nSerious adverse reactions occurred in 42% of patients who received Retevmo in\nLIBRETTO-121. Serious adverse reactions occurring in more than 1 patient were\nvomiting and fracture (2 patients each).\n\nSerious adverse reactions occurred in 35% of patients who received Retevmo in\nLIBRETTO-431. The most frequently reported serious adverse reactions (≥2%\nof patients) were pleural effusion and abnormal hepatic function. Fatal\nadverse reactions occurred in 4.4% of patients who received Retevmo in\nLIBRETTO-431; fatal adverse reactions included myocardial infarction (n=2),\nrespiratory failure (n=2), cardiac arrest, malnutrition, and sudden death (n=1\neach).\n\nSerious adverse reactions occurred in 22% of patients who received Retevmo in\nLIBRETTO-531. The most frequent serious adverse reactions were pneumonia and\npyrexia (n=3 each), and hypertension and urinary tract infection (n=2 each).\nFatal adverse reactions occurred in 2.1% of patients who received Retevmo in\nLIBRETTO-531; fatal adverse reactions included COVID19, diabetic ketoacidosis,\nmultiple organ dysfunction syndrome, and sudden death (n=1 each).\n\nCommon adverse reactions (all grades) occurring in ≥20% of patients who\nreceived Retevmo in LIBRETTO-001 were musculoskeletal pain (59%), edema\n(53%), diarrhea (52%), fatigue (49%), dry mouth (44%), hypertension (43%),\nabdominal pain (39%), rash (38%), nausea (36%), constipation (35%), cough\n(30%), headache (30%), vomiting (29%), dyspnea (28%), hemorrhage (26%),\ndecreased appetite (23%), dizziness (22%), prolonged QT interval (21%), and\nurinary tract infection (20%).\n\nCommon adverse reactions (all grades) occurring in ≥15% of patients who\nreceived Retevmo in LIBRETTO-121 were musculoskeletal pain (58%), diarrhea\n(47%), nausea (42%), hemorrhage (39%), pyrexia (39%), abdominal pain (36%),\nheadache (33%), vomiting (31%), fatigue (31%), cough (31%), rash (28%),\ncoronavirus infection (28%), upper respiratory tract infection (28%), edema\n(25%), constipation (22%), oropharyngeal pain (22%), hypothyroidism (22%),\nurinary tract infection (19%), and increased weight (19%).\n\nCommon adverse reactions (all grades) occurring in ≥15% of patients who\nreceived Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431\nwere hypertension (48% vs 7%), diarrhea (44% vs 24%), edema (41% vs 28%), dry\nmouth (39% vs 6%), rash (33% vs 30%), fatigue (32% vs 50%), abdominal pain\n(25% vs 19%), musculoskeletal pain (25% vs 28%), constipation (22% vs 40%),\nelectrocardiogram QT prolonged (20% vs 1.0%), COVID19 infection (19% vs 18%),\nstomatitis (18% vs 16%), decreased appetite (17% vs 34%), nausea (13% vs 44%),\nvomiting (13% vs 23%), and pyrexia (13% vs 23%).\n\nCommon adverse reactions (all grades) occurring in ≥10% of patients who\nreceived Retevmo in LIBRETTO-531 (Retevmo vs cabozantinib / vandetanib) were\nhypertension (43% vs 41%), edema (33% vs 5%), dry mouth (32% vs 10%), fatigue\n(28% vs 47%), diarrhea (26% vs 61%), headache (23% vs 21%), rash (19% vs 27%),\nabdominal pain (18% vs 21%), constipation (16% vs 12%), erectile dysfunction\n(16% vs 0%), stomatitis (14% vs 42%), electrocardiogram QT prolonged (14% vs\n13%), pyrexia (12% vs 2.1%), decreased appetite (12% vs 28%), hypothyroidism\n(11% vs 21%), and nausea (10% vs 32%).\n\nLaboratory abnormalities (all grades ≥20%; Grade 3-4) worsening from\nbaseline in patients who received Retevmo in LIBRETTO-001, were increased AST\n(62%; 11%), decreased calcium (61%; 7%), decreased albumin (61%; 3.6%),\nincreased ALT (58%; 13%), increased glucose (56%; 4.0%), decreased lymphocytes\n(56%; 22%), increased creatinine (51%; 3.6%), decreased sodium (49%; 13%),\nincreased alkaline phosphatase (43%; 4.4%), decreased platelets (41%; 4.0%),\nincreased potassium (39%; 3.5%), decreased glucose (39%; 1.5%), increased\ntotal cholesterol (37%; 1.7%), decreased magnesium (37%; 0.7%), decreased\nhemoglobin (36%; 4.1%), increased bilirubin (32%; 2.9%), decreased neutrophils\n(27%; 3.8%), and decreased phosphate (25%; 5%).\n\nLaboratory abnormalities (all grades ≥15%; Grade 3-4) worsening from\nbaseline in patients who received Retevmo in LIBRETTO-121 were decreased\ncalcium (61%; 11%), increased ALT (58%; 8%), decreased albumin (53%; 0%),\nincreased alkaline phosphatase (50%; 0%), increased AST (50%; 2.8%), increased\nbilirubin (31%; 2.8%), increased cholesterol (28%, 0%), decreased magnesium\n(28%; 6%), increased potassium (28%; 2.8%), increased creatinine (19%, 2.8%),\ndecreased potassium (19%, 6%), decreased sodium (17%, 0%), decreased\nneutrophils (40%; 8%), decreased hemoglobin (36%; 11%), increased hemoglobin\n(33%, 2.8%), decreased platelets (28%; 2.8%), and decreased lymphocytes (28%;\n14%).\n\nLaboratory abnormalities (all grades ≥20%; Grade 3-4) worsening from\nbaseline in patients who received Retevmo or chemotherapy with or without\npembrolizumab in LIBRETTO-431 were increased ALT (81%; 21% vs 63%; 4.1%),\nincreased AST (77%; 10% vs 46%; 0%), decreased calcium (53%; 1.9% vs 24%;\n1.0%), decreased platelets (53%; 3.2% vs 39%; 5%), decreased lymphocytes (53%;\n8% vs 64%; 15%), decreased neutrophils (53%; 2.0% vs 58%; 11%), increased\nbilirubin (52%; 1.3% vs 9%; 0%), increased alkaline phosphatase (35%; 1.3% vs\n22%; 0%), decreased sodium (31%; 3.2% vs 41%; 2.1%), decreased albumin (25%;\n0% vs 5%; 0%), increased blood creatinine (23%; 0% vs 21%; 0%), decreased\nhemoglobin (21%; 0% vs 91%; 5%), decreased potassium (17%; 1.3% vs 15%; 1.0%),\nand decreased magnesium (16%; 0.6% vs 8%; 0%).\n\nLaboratory abnormalities (all grades ≥5%; Grade 3-4) worsening from baseline\nin patients who received Retevmo in LIBRETTO-531 (Retevmo vs cabozantinib /\nvandetanib) were decreased calcium (55%; 5% vs 62%; 11%), increased ALT (53%;\n16% vs 72%; 7%), increased AST (47%; 5% vs 68%; 3.2%), decreased lymphocytes\n(41%; 18% vs 36%; 13%), increased alkaline phosphatase (37%; 6% vs 28%, 5%),\nincreased bilirubin (32%; 1.1% vs 30%; 3.2%), decreased neutrophils (33%; 14%\nvs 42%; 19%), decreased platelets (28%; 1.1% vs 34%; 1.1%), increased\ncreatinine (27%; 6% vs 16%; 8%), decreased sodium (20%; 3.2% vs 16%; 0%),\ndecreased hemoglobin (18%; 2.1% vs 23%; 2.1%), decreased albumin (11%; 1.1% vs\n7%; 0%), decreased magnesium (9%; 3.3% vs 26%; 9%), and decreased potassium\n(8%; 0% vs 22%; 4.4%).\n\nConcomitant use of acid-reducing agents decreases selpercatinib plasma\nconcentrations which may reduce Retevmo anti-tumor activity. Avoid concomitant\nuse of proton-pump inhibitors (PPIs), histamine-2 (H2) receptor antagonists,\nand locally acting antacids with Retevmo. If coadministration cannot be\navoided, take Retevmo with food (with a PPI) or modify its administration time\n(with a H2 receptor antagonist or a locally acting antacid).\n\nConcomitant use of strong and moderate CYP3A inhibitors increases\nselpercatinib plasma concentrations which may increase the risk of Retevmo\nadverse reactions including QTc interval prolongation. Avoid concomitant use\nof strong and moderate CYP3A inhibitors with Retevmo. If concomitant use of a\nstrong or moderate CYP3A inhibitor cannot be avoided, reduce the Retevmo\ndosage as recommended and monitor the QT interval with ECGs more frequently.\n\nConcomitant use of strong and moderate CYP3A inducers decreases selpercatinib\nplasma concentrations which may reduce Retevmo anti-tumor activity. Avoid\ncoadministration of Retevmo with strong and moderate CYP3A inducers.\n\nConcomitant use of Retevmo with CYP2C8 and CYP3A substrates increases their\nplasma concentrations which may increase the risk of adverse reactions related\nto these substrates. Avoid coadministration of Retevmo with CYP2C8 and CYP3A\nsubstrates where minimal concentration changes may lead to increased adverse\nreactions. If coadministration cannot be avoided, follow recommendations for\nCYP2C8 and CYP3A substrates provided in their approved product labeling.\n\nRetevmo is a P-glycoprotein (P-gp) and BCRP inhibitor. Concomitant use of\nRetevmo with P-gp or BCRP substrates increases their plasma concentrations,\nwhich may increase the risk of adverse reactions related to these substrates.\nAvoid coadministration of Retevmo with P-gp or BCRP substrates where minimal\nconcentration changes may lead to increased adverse reactions. If\ncoadministration cannot be avoided, follow recommendations for P-gp and BCRP\nsubstrates provided in their approved product labeling.\n\nThe safety and effectiveness of Retevmo have not been established in pediatric\npatients less than 2 years of age. The safety and effectiveness of Retevmo\nhave been established in pediatric patients aged 2 years and older for the\ntreatment of advanced or metastatic medullary thyroid cancer (MTC) with a RET\nmutation who require systemic therapy, advanced or metastatic thyroid cancer\nwith a RET gene fusion who require systemic therapy and are radioactive\niodine-refractory (if radioactive iodine is appropriate), and locally advanced\nor metastatic solid tumors with a RET gene fusion that have progressed on or\nfollowing prior systemic treatment or who have no satisfactory alternative\ntreatment options.\n\nMonitor open growth plates in pediatric patients. Consider interrupting or\ndiscontinuing Retevmo if abnormalities occur.\n\nNo dosage modification is recommended for patients with mild to severe renal\nimpairment (estimated Glomerular Filtration Rate [eGFR] ≥15 to 89 mL/min,\nestimated by Modification of Diet in Renal Disease [MDRD] equation). A\nrecommended dosage has not been established for patients with end-stage renal\ndisease.\n\nReduce the dose when administering Retevmo to patients with severe hepatic\nimpairment (total bilirubin greater than 3 to 10 times upper limit of normal\n[ULN] and any AST). No dosage modification is recommended for patients with\nmild or moderate hepatic impairment. Monitor for Retevmo-related adverse\nreactions in patients with hepatic impairment.\n\nRetevmo (selpercatinib) is available as 40 mg and 80 mg capsules, and 40 mg,\n80 mg, 120 mg, and 160 mg tablets.\n\nSE HCP ISI All_JUL2026\n\nPlease see full Prescribing Information\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=1731664991&u=https%3A%2F%2Fpi.lilly.com%2Fus%2Fretevmo-uspi.pdf&a=Prescribing+Information)\nand Instructions for Use\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=725668258&u=http%3A%2F%2Fuspl.lilly.com%2Fretevmo%2Fretevmo.html%3Fs%3Dug0&a=Instructions+for+Use)\nfor Retevmo.\n\nAbout Verzenio (abemaciclib)\nVerzenio (abemaciclib) is approved to treat people with certain HR+, HER2–\nbreast cancers in the adjuvant and advanced or metastatic settings. Verzenio\nis an oral tablet taken twice daily and available in strengths of 50 mg, 100\nmg, 150 mg, and 200 mg. Discovered and developed by Lilly researchers,\nVerzenio was first approved in 2017 and is authorized for use in more than 90\ncountries around the world. For full details on indicated uses of Verzenio in\nHR+, HER2– breast cancer, please see full Prescribing Information\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=2600874321&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4777053-1%26h%3D2587940306%26u%3Dhttps%253A%252F%252Fuspl.lilly.com%252Fverzenio%252Fverzenio.html%253Fs%253Dpi%26a%3DPrescribing%2BInformation%252C&a=Prescribing+Information)\n, available at www.Verzenio.com\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=841025049&u=https%3A%2F%2Fverzenio.lilly.com%2F%3Fredirect-referrer%3Dhttps%253A%252F%252Fword-edit.officeapps.live.com%252F&a=www.Verzenio.com)\n.\n\nINDICATIONS FOR VERZENIO\n\nVerzenio (abemaciclib) is a kinase inhibitor indicated(8,9):\n\n * in combination with endocrine therapy (tamoxifen or an aromatase inhibitor)\nfor the adjuvant treatment of adults with hormone receptor (HR)-positive,\nhuman epidermal growth factor receptor 2 (HER2)-negative, node-positive, early\nbreast cancer at high risk of recurrence.\n * in combination with an aromatase inhibitor as initial endocrine-based therapy\nfor the treatment of adults with HR-positive, HER2-negative advanced or\nmetastatic breast cancer.\n * in combination with fulvestrant for the treatment of adults with HR-positive,\nHER2-negative advanced or metastatic breast cancer with disease progression\nfollowing endocrine therapy.\n * in combination with Inluriyo for the treatment of adults with estrogen\nreceptor (ER)-positive, HER2-negative, estrogen receptor-1 (ESR1)-mutated\nadvanced or metastatic breast cancer, as detected by an FDA-authorized test,\nwith disease progression following at least one line of endocrine therapy.\n * as monotherapy for the treatment of adults with HR-positive, HER2-negative\nadvanced or metastatic breast cancer with disease progression following\nendocrine therapy and prior chemotherapy in the metastatic setting.\nIMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib)\nSevere diarrhea associated with dehydration and infection occurred in\npatients treated with Verzenio. Across five clinical trials in 3899 patients,\ndiarrhea occurred in 81% to 90% of patients who received Verzenio. Grade 3\ndiarrhea occurred in 8% to 20% of patients receiving Verzenio. Most patients\nexperienced diarrhea during the first month of Verzenio treatment. The median\ntime to onset of the first diarrhea event ranged from 6 to 8 days; and the\nmedian duration of Grade 2 and Grade 3 diarrhea ranged from 6 to 11 days and 5\nto 8 days, respectively. Across trials, 19% to 26% of patients with diarrhea\nrequired a Verzenio dose interruption and 13% to 23% required a dose\nreduction.\n\nInstruct patients to start antidiarrheal therapy such as loperamide at the\nfirst sign of loose stools, increase oral fluids, and notify their healthcare\nprovider for further instructions and appropriate follow-up. For Grade 3 or 4\ndiarrhea, or diarrhea that requires hospitalization, withhold Verzenio until\nresolution to ≤Grade 1, and then resume Verzenio at the next lower dose.\n\nNeutropenia, including febrile neutropenia and fatal neutropenic sepsis,\noccurred in patients treated with Verzenio. Across five clinical trials in\n3899 patients, neutropenia occurred in 37% to 51% of patients receiving\nVerzenio. A Grade ≥3 decrease in neutrophil count (based on laboratory\nfindings) occurred in 19% to 32% of patients receiving Verzenio.\n\nAcross trials, the median time to first episode of Grade ≥3 neutropenia\nranged from 29 days to 34 days, and the median duration of Grade ≥3\nneutropenia ranged from 10 days to 16 days.\n\nFebrile neutropenia has been reported in <1% of patients exposed to\nVerzenio across trials. Two deaths due to neutropenic sepsis were observed in\nMONARCH 2. Inform patients to promptly report any episodes of fever to their\nhealthcare provider.\n\nMonitor complete blood counts prior to the start of Verzenio therapy, every 2\nweeks for the first 2 months, monthly for the next 2 months, and as clinically\nindicated. Dose interruption, dose reduction, or delay in starting treatment\ncycles is recommended for patients who develop Grade 3 or 4 neutropenia.\n\nSevere, life-threatening, or fatal interstitial lung disease (ILD) or\npneumonitis can occur in patients treated with Verzenio and other CDK4/6\ninhibitors. In Verzenio-treated patients in early breast cancer (monarchE,\nN=2791), 3% of patients experienced ILD or pneumonitis of any grade: 0.4% were\nGrade 3 or 4 and there was one fatality (0.1%). In Verzenio-treated patients\nin advanced or metastatic breast cancer (N=1108) (MONARCH 1, MONARCH 2,\nMONARCH 3, EMBER-3), 3.2% of Verzenio-treated patients had ILD or pneumonitis\nof any grade: 0.5% had Grade 3 or 4, and 0.5% had fatal outcomes. Additional\ncases of ILD or pneumonitis have been observed in the postmarketing setting,\nwith fatalities reported.\n\nMonitor patients for pulmonary symptoms indicative of ILD or pneumonitis.\nSymptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on\nradiologic exams. Infectious, neoplastic, and other causes for such symptoms\nshould be excluded by means of appropriate investigations.\n\nWithhold or reduce dose for patients who develop persistent or recurrent Grade\n2 ILD or pneumonitis. Permanently discontinue VERZENIO in all patients with\nGrade 3 or 4 ILD or pneumonitis.\n\nGrade ≥3 increases in alanine aminotransferase (ALT) (2% to 6%) and\naspartate aminotransferase (AST) (2% to 3%) were reported in patients\nreceiving Verzenio.\n\nAcross four clinical trials in 3767 patients (monarchE, MONARCH 2, MONARCH 3,\nEMBER-3), the median time to onset of Grade ≥3 ALT increases ranged from 57\nto 87 days and the median time to resolution to Grade <3 was 13 to 14 days.\nThe median time to onset of Grade ≥3 AST increases ranged from 71 to 185\ndays and the median time to resolution to Grade <3 ranged from 11 to 15\ndays.\n\nMonitor liver function tests (LFTs) prior to the start of VERZENIO therapy,\nevery 2 weeks for the first 2 months, monthly for the next 2 months, and as\nclinically indicated. Dose interruption, dose reduction, dose discontinuation,\nor delay in starting treatment cycles is recommended for patients who develop\npersistent or recurrent Grade 2, or any Grade 3 or Grade 4 hepatic\ntransaminase elevation.\n\nVenous thromboembolic events (VTE) were reported in 2% to 5% of patients\ntreated with Verzenio across four clinical trials in 3767 patients (monarchE,\nMONARCH 2, MONARCH 3, EMBER-3). VTE events included deep vein thrombosis,\npulmonary embolism, pelvic venous thrombosis, cerebral venous sinus\nthrombosis, subclavian and axillary vein thrombosis, inferior vena cava\nthrombosis, jugular vein thrombosis, peripheral vein thrombosis and\nsuperficial vein thrombosis. In clinical trials, deaths due to VTE occurred in\npatients treated with Verzenio.\n\nVerzenio has not been studied in patients with early breast cancer who had a\nhistory of VTE. Monitor patients for signs and symptoms of venous thrombosis\nand pulmonary embolism and treat as medically appropriate. Dose interruption\nis recommended for early breast cancer patients with any grade VTE event and\nfor advanced or metastatic breast cancer patients with a Grade 3 or 4 VTE\nevent.\n\nVerzenio can cause fetal harm when administered to a pregnant woman, based on\nfindings from animal studies and the mechanism of action. In animal\nreproduction studies, administration of abemaciclib to pregnant rats during\nthe period of organogenesis caused teratogenicity and decreased fetal weight\nat maternal exposures that were similar to the human clinical exposure based\non area under the curve (AUC) at the maximum recommended human dose.\n\nAdvise pregnant women of the potential risk to a fetus. Advise females of\nreproductive potential to use effective contraception during treatment with\nVerzenio and for 3 weeks after the last dose.\n\nVerzenio can increase serum creatinine without affecting renal function.\nThese increases were not associated with changes in glomerular function. In\nEMBER-3, creatinine increase occurred in 36% for all grades (Grade 3 or 4:\n1.1%) of patients who received Inluriyo in combination with Verzenio. During\nVerzenio treatment, use alternative measures that are not based on serum\ncreatinine to assess renal function such as BUN, cystatin C, or calculated\nGFR.\n\nThe most common adverse reactions (all grades, ≥10%) observed in monarchE\nfor Verzenio plus tamoxifen or an aromatase inhibitor vs tamoxifen or an\naromatase inhibitor, with a difference between arms of ≥2%, were diarrhea\n(84% vs 9%), infections (51% vs 39%), neutropenia (46% vs 6%), fatigue (41% vs\n18%), leukopenia (38% vs 7%), nausea (30% vs 9%), anemia (24% vs 4%), headache\n(20% vs 15%), vomiting (18% vs 4.6%), stomatitis (14% vs 5%), lymphopenia (14%\nvs 3%), thrombocytopenia (13% vs 2%), decreased appetite (12% vs 2.4%), ALT\nincreased (12% vs 6%), AST increased (12% vs 5%), dizziness (11% vs 7%), rash\n(11% vs 4.5%), and alopecia (11% vs 2.7%).\n\nThe most frequently reported ≥5% Grade 3 or 4 adverse reaction that\noccurred in the Verzenio arm vs the tamoxifen or an aromatase inhibitor arm of\nmonarchE were neutropenia (19.6% vs 1%), leukopenia (11% vs <1%), diarrhea\n(8% vs 0.2%), and lymphopenia (5% vs <1%).\n\nLab abnormalities (all grades; Grade 3 or 4) for monarchE in ≥10% for\nVerzenio plus tamoxifen or an aromatase inhibitor with a difference between\narms of ≥2% were increased serum creatinine (99% vs 91%; 0.5% vs <0.1%),\ndecreased white blood cells (89% vs 28%; 19.1% vs 1.1%), decreased neutrophil\ncount (84% vs 23%; 18.7% vs 1.9%), anemia (68% vs 17%; 1% vs .1%), decreased\nlymphocyte count (59% vs 24%; 13.2% vs 2.5%), decreased platelet count (37% vs\n10%; .9% vs .2%), increased ALT (37% vs 24%; 2.6% vs 1.2%), increased AST (31%\nvs 18%; 1.6% vs .9%), and hypokalemia (11% vs 3.8%; 1.3% vs 0.2%).\n\nThe most common adverse reactions (all grades, ≥10%) observed in MONARCH 3\nfor Verzenio plus anastrozole or letrozole vs anastrozole or letrozole, with a\ndifference between arms of ≥2%, were diarrhea (81% vs 30%), fatigue (40% vs\n32%), neutropenia (41% vs 2%), infections (39% vs 29%), nausea (39% vs 20%),\nabdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs 5%),\nalopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia (21% vs 2%),\ncreatinine increased (19% vs 4%), constipation (16% vs 12%), ALT increased\n(16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), pruritus (13% vs\n9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight\ndecreased (10% vs 3.1%), influenza-like illness (10% vs 8%), and\nthrombocytopenia (10% vs 2%).\n\nThe most frequently reported ≥5% Grade 3 or 4 adverse reactions that\noccurred in the Verzenio arm vs the placebo arm of MONARCH 3 were neutropenia\n(22% vs 1%), diarrhea (9% vs 1.2%), leukopenia (7% vs <1%)), increased ALT\n(6% vs 2%), and anemia (6% vs 1%).\n\nLab abnormalities (all grades; Grade 3 or 4) for MONARCH 3 in ≥10% for\nVerzenio plus anastrozole or letrozole with a difference between arms of ≥2%\nwere increased serum creatinine (98% vs 84%; 2.2% vs 0%), decreased white\nblood cells (82% vs 27%; 13% vs 0.6%), anemia (82% vs 28%; 1.6% vs 0%),\ndecreased neutrophil count (80% vs 21%; 21.9% vs 2.6%), decreased lymphocyte\ncount (53% vs 26%; 7.6% vs 1.9%), decreased platelet count (36% vs 12%; 1.9%\nvs 0.6%), increased ALT (48% vs 25%; 6.6% vs 1.9%), and increased AST (37% vs\n23%; 3.8% vs 0.6%).\n\nThe most common adverse reactions (all grades, ≥10%) observed in MONARCH 2\nfor Verzenio plus fulvestrant vs fulvestrant, with a difference between arms\nof ≥2%, were diarrhea (86% vs 25%), neutropenia (46% vs 4%), fatigue (46%\nvs 32%), nausea (45% vs 23%), infections (43% vs 25%), abdominal pain (35% vs\n16%), anemia (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs\n12%), vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 2.7%),\nthrombocytopenia (16% vs 3%), alopecia (16% vs 1.8%), stomatitis (15% vs 10%),\nALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), dizziness\n(12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 7%),\ncreatinine increased (12% vs <1%), rash (11% vs 4.5%), pyrexia (11% vs 6%),\nand weight decreased (10% vs 2.2%).\n\nThe most frequently reported ≥5% Grade 3 or 4 adverse reactions that\noccurred in the Verzenio arm vs the placebo arm of MONARCH 2 were neutropenia\n(25% vs 1%), diarrhea (13% vs 0.4%), leukopenia (9% vs 0%), anemia (7% vs 1%),\nand infections (5.7% vs 3.5%).\n\nLab abnormalities (all grades; Grade 3 or 4) for MONARCH 2 in ≥10% for\nVerzenio plus fulvestrant with a difference between arms of ≥2% were\nincreased serum creatinine (98% vs 74%; 1.2% vs 0%), decreased white blood\ncells (90% vs 33%; 23.7% vs .9%), decreased neutrophil count (87% vs 30%;\n32.5% vs 4.2%), anemia (84% vs 34%; 2.6% vs .5%), decreased lymphocyte count\n(63% vs 32%; 12.2% vs 1.8%), decreased platelet count (53% vs 15%; 2.1% vs\n0%), increased ALT (41% vs 32%; 4.6% vs 1.4%), and increased AST (37% vs 25%;\n3.9% vs 4.2%).\n\nThe most common adverse reactions (all grades, ≥10%) observed in MONARCH\n1 with Verzenio were diarrhea (90%), fatigue (65%), nausea (64%), decreased\nappetite (45%), abdominal pain (39%), neutropenia (37%), vomiting (35%),\ninfections (31%), anemia (25%), thrombocytopenia (20%), headache (20%), cough\n(19%), constipation (17%), leukopenia (17%), arthralgia (15%), dry mouth\n(14%), weight decreased (14%), stomatitis (14%), creatinine increased (13%),\nalopecia (12%), dysgeusia (12%), pyrexia (11%), dizziness (11%), and\ndehydration (10%).\n\nThe most frequently reported ≥5% Grade 3 or 4 adverse reactions from MONARCH\n1 with Verzenio were diarrhea (20%), neutropenia (24%), fatigue (13%), and\nleukopenia (5%).\n\nLab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 with Verzenio were\nincreased serum creatinine (99%; .8%), decreased white blood cells (91%; 28%),\ndecreased neutrophil count (88%; 26.6%), anemia (69%; 0%), decreased\nlymphocyte count (42%; 13.8%), decreased platelet count (41%; 2.3%), increased\nALT (31%; 3.1%), and increased AST (30%; 3.8%).\n\nSerious and Fatal Adverse Reactions for Inluriyo in combination with\nVerzenio: Serious adverse reactions occurred in 21% of patients who received\nInluriyo in combination with Verzenio. Serious adverse reactions in >1% of\npatients who received Inluriyo in combination with Verzenio included pneumonia\n(2.4%), abdominal pain, and renal failure (each 1.4%). Fatal adverse\nreactions occurred in 3.8% of patients who received Inluriyo in combination\nwith Verzenio, including pneumonia (1.4%), myocardial infarction, interstitial\nlung disease, and sepsis (0.5% each).\n\nMost Common Adverse Reactions for Inluriyo in combination with Verzenio: The\nmost common (≥10%) adverse reactions with Inluriyo in combination with\nVerzenio, including laboratory abnormalities, were decreased neutrophils,\ndiarrhea, decreased hemoglobin, decreased lymphocytes, nausea, decreased\nplatelets, fatigue, increased triglycerides, infections, increased AST,\nincreased creatinine, increased ALT, vomiting, musculoskeletal pain, abdominal\npain, decreased appetite, increased cholesterol, rash, cough, headache, and\ndecreased weight.\n\nStrong and moderate CYP3A inhibitors increased the exposure of abemaciclib\nplus its active metabolites to a clinically meaningful extent and may lead to\nincreased toxicity. Avoid concomitant use of ketoconazole. Ketoconazole is\npredicted to increase the AUC of abemaciclib by up to 16-fold. In patients\nwith recommended starting doses of 200 mg twice daily or 150 mg twice daily,\nreduce the Verzenio dose to 100 mg twice daily with concomitant use of strong\nCYP3A inhibitors other than ketoconazole. In patients who have had a dose\nreduction to 100 mg twice daily due to adverse reactions, further reduce the\nVerzenio dose to 50 mg twice daily with concomitant use of strong CYP3A\ninhibitors. If a patient taking Verzenio discontinues a strong CYP3A\ninhibitor, increase the Verzenio dose (after 3-5 half-lives of the inhibitor)\nto the dose that was used before starting the inhibitor. Patients should avoid\ngrapefruit products. With concomitant use of moderate CYP3A inhibitors,\nmonitor for adverse reactions and consider reducing the Verzenio dose in 50 mg\ndecrements.\n\nAvoid concomitant use of strong or moderate CYP3A inducers and consider\nalternative agents. Coadministration of strong or moderate CYP3A inducers\ndecreased the plasma concentrations of abemaciclib plus its active metabolites\nand may lead to reduced activity.\n\nWith severe hepatic impairment (Child-Pugh C), reduce the Verzenio dosing\nfrequency to once daily. No dosage adjustments are necessary in patients with\nmild or moderate hepatic impairment (Child-Pugh A or B).\n\nPlease see full Prescribing Information\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=1650388117&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4041638-1%26h%3D1452747158%26u%3Dhttps%253A%252F%252Fpi.lilly.com%252Fus%252Fverzenio-uspi.pdf%26a%3DPrescribing%2BInformation&a=Prescribing+Information)\nand Patient Information\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=462798302&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4041638-1%26h%3D1439763023%26u%3Dhttps%253A%252F%252Fpi.lilly.com%252Fus%252Fverzenio-us-ppi.pdf%26a%3DPatient%2BInformation&a=Patient+Information)\nfor Verzenio.\n\nVZ IN HCP ISI ALL APPR\n\nAbout Lilly\nLilly is a medicine company turning science into healing to make life better\nfor people around the world. We've been pioneering life-changing discoveries\nfor 150 years, and today our medicines help tens of millions of people across\nthe globe. Harnessing the power of biotechnology, chemistry and genetic\nmedicine, our scientists are urgently advancing new discoveries to solve some\nof the world's most significant health challenges: redefining diabetes care;\ntreating obesity and curtailing its most devastating long-term effects;\nadvancing the fight against Alzheimer's disease; providing solutions to some\nof the most debilitating immune system disorders; and transforming the most\ndifficult-to-treat cancers into manageable diseases. With each step toward a\nhealthier world, we're motivated by one thing: making life better for millions\nmore people. That includes delivering innovative clinical trials that reflect\nthe diversity of our world and working to ensure our medicines are accessible\nand affordable. To learn more, visit Lilly.com\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=973415295&u=https%3A%2F%2Fwww.lilly.com%2F%3Futm_source%3Dpr%26utm_medium%3Dreferral%26utm_campaign%3Dpr_boilerplate&a=Lilly.com)\n and Lilly.com/news\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=1160456343&u=https%3A%2F%2Fwww.lilly.com%2Fnews%3Futm_source%3Dpr%26utm_medium%3Dreferral%26utm_campaign%3Dpr_boilerplate&a=Lilly.com%2Fnews)\n, or follow us on Facebook\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=3433208564&u=https%3A%2F%2Fwww.facebook.com%2Felilillyandco%2F&a=Facebook)\n, Instagram\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=246100894&u=https%3A%2F%2Fwww.instagram.com%2Felilillyco%2F&a=Instagram)\n, and LinkedIn\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=975317160&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Feli-lilly-and-company%2F&a=LinkedIn)\n. P-LLY\n\nTrademarks and Trade Names\nAll trademarks or trade names referred to in this press release are the\nproperty of the company, or, to the extent trademarks or trade names belonging\nto other companies are references in this press release, the property of their\nrespective owners. Solely for convenience, the trademarks and trade names in\nthis press release are referred to without the (®) and ™ symbols, but such\nreferences should not be construed as any indicator that the company or, to\nthe extent applicable, their respective owners will not assert, to the fullest\nextent under applicable law, the company's or their rights thereto. We do not\nintend the use or display of other companies' trademarks and trade names to\nimply a relationship with, or endorsement or sponsorship of us by, any other\ncompanies.\n\nCautionary Statement Regarding Forward-Looking Statements\nThis press release contains forward-looking statements (as that term is\ndefined in the Private Securities Litigation Reform Act of 1995) about\nsofetabart mipitecan as a potential treatment for ovarian cancer as well as\nother FRα-expressing solid tumors, olomorasib as a potential treatment for\ncertain KRAS G12C-mutant advanced solid tumors, Retevmo (selpercatinib) as a\ntreatment for advanced RET-mutant medullary thyroid cancer (MTC), and Verzenio\n(abemaciclib) as a treatment for certain HR+, HER2– breast cancers in the\nadjuvant and advanced or metastatic setting, and reflects Lilly's current\nbeliefs and expectations. However, as with any pharmaceutical product, there\nare substantial risks and uncertainties in the process of drug research,\ndevelopment, and commercialization. Among other things, there is no guarantee\nthat planned or ongoing studies will be completed as planned, that future\nstudy results will be consistent with study results to date, that any of these\ntherapies will prove to be a safe and effective treatment or receive\nregulatory approval, or that Lilly will execute its strategy as expected. For\nfurther discussion of these and other risks and uncertainties that could cause\nactual results to differ from Lilly's expectations, see Lilly's Form 10-K and\nForm 10-Q filings with the United States Securities and Exchange Commission.\nExcept as required by law, Lilly undertakes no duty to update forward-looking\nstatements to reflect events after the date of this release.\n\nEndnotes & References\n\n 1. Bax, Heather J et al. \"Folate receptor alpha in ovarian cancer tissue and\npatient serum is associated with disease burden and treatment outcomes.\"\nBritish journal of cancer vol. 128,2 (2023): 342-353.\ndoi:10.1038/s41416-022-02031-x\n 2. Scaranti, Mariana et al. \"Exploiting the folate receptor α in oncology.\"\nNature reviews. Clinical oncology vol. 17,6 (2020): 349-359.\ndoi:10.1038/s41571-020-0339-5.\n 3. Kalli, Kimberly R et al. \"Folate receptor alpha as a tumor target in\nepithelial ovarian cancer.\" Gynecologic oncology vol. 108,3 (2008): 619-26.\ndoi:10.1016/j.ygyno.2007.11.020.\n 4. Viricel W, et al. Cancer Res. 2023;83(suppl 7):1544.\n 5. Ji J, Wang C, Fakih M. Targeting KRAS G12C-mutated advanced colorectal cancer:\nResearch and clinical developments. OncoTargets and Therapy. 2022;Volume\n15:747-756. doi:10.2147/ott.s340392\n 6. Peng S-B, Si C, Zhang Y, et al. Abstract 1259: Preclinical characterization of\nLY3537982, a novel, highly selective and potent KRAS-G12C inhibitor. Cancer\nResearch. 2021;81(13_Supplement):1259-1259. doi:10.1158/1538-7445.am2021-1259\n 7. Retevmo. Prescribing information. Lilly USA, LLC.\n 8. Verzenio. Prescribing information. Lilly USA, LLC.\n 9. Inluriyo. Prescribing information. Lilly USA, LLC.\nRefer to:  Megan Talon; megan.talon@lilly.com (mailto:megan.talon@lilly.com)\n(Media)\n                 Michael Czapar; czapar_michael_c@lilly.com\n(mailto:czapar_michael_c@lilly.com) (Investors)\n\n \n\nView original content to download\nmultimedia:https://www.prnewswire.com/news-releases/lilly-to-showcase-advances-across-its-oncology-pipeline-at-the-2026-european-society-for-medical-oncology-esmo-congress-302911565.html\n(https://www.prnewswire.com/news-releases/lilly-to-showcase-advances-across-its-oncology-pipeline-at-the-2026-european-society-for-medical-oncology-esmo-congress-302911565.html)\n\nSOURCE Eli Lilly and Company\n\n\n\nPhoto: \nhttps://mmx.prnewswire.com/media/MS270365/ELI-LILLY-AND-COMPANY-LOGO.jpg?id=OA3022173\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPn6bwDQba-20261018","title":"Lilly to showcase advances across its oncology pipeline at the 2026 European Society for Medical Oncology (ESMO) Congress","author":"PR Newswire","ticker":"LLY","created":"2026-10-18T22:05:00.022Z","tickers":["LLY"],"exchange":"NYSE","article_body":"Lilly to showcase advances across its oncology pipeline at the 2026 European Society for Medical Oncology (ESMO) Congress\nPR Newswire\n\nINDIANAPOLIS, Oct. 18, 2026\n\nFirst Phase 1 data for sofetabart mipitecan, Lilly's investigational\nFRα-targeting ADC, in platinum-sensitive ovarian cancer to be featured in a\nrapid oral presentation\n\nUpdated first-line data for olomorasib, an investigational therapy targeting\nKRAS G12C-mutant NSCLC, to be featured in a rapid oral presentation\n\nUpdated Phase 3 data for selpercatinib versus cabozantinib or vandetanib in\nadvanced, kinase inhibitor-naïve, RET-mutant MTC to be shared in a proffered\npaper\n\nINDIANAPOLIS, Oct. 18, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)\ntoday announced that new data from across its oncology portfolio will be\npresented at the European Society for Medical Oncology\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=277139152&u=https%3A%2F%2Fwww.esmo.org%2Fmeeting-calendar%2Fesmo-congress-2026&a=European+Society+for+Medical+Oncology)\n (ESMO) Congress, taking place October 23–27 in Madrid, Spain. Highlights\ninclude new Phase 1 data in platinum-sensitive ovarian cancer (PSOC) for\nsofetabart mipitecan (Sofe-M), Lilly's investigational FRα-targeting\nantibody-drug conjugate (ADC), in combination with bevacizumab, along with\nupdated findings for olomorasib, Retevmo (selpercatinib), and Verzenio\n(abemaciclib) in lung, thyroid, and breast cancers, respectively.\n\nKey Presentation Highlights:\n\nSofetabart mipitecan (Sofe-M; FRα-targeting ADC): A rapid oral presentation\non first Phase 1 data for sofetabart mipitecan plus bevacizumab in patients\nwith PSOC. These data support the ongoing Phase 3 clinical trial of Sofe-M in\nPSOC.\n\nOlomorasib (investigational KRAS G12C inhibitor):\nA rapid oral presentation on an updated integrated analysis from the Phase 1/2\nLOXO-RAS-20001 trial and the safety lead-in portion of the Phase 3 SUNRAY-01\ntrial, assessing olomorasib in combination with chemoimmunotherapy\n(pembrolizumab, pemetrexed, and platinum) as potential first-line treatments\nfor patients with advanced/metastatic KRAS G12C-mutant non-small cell lung\ncancer (NSCLC). These data support the ongoing Phase 3 clinical trial of\nolomorasib in first-line KRAS G12C-mutant lung cancer.\n\nRetevmo (selpercatinib; RET kinase inhibitor): A proffered paper presentation\non updated results from the Phase 3 LIBRETTO-531 study\nof selpercatinib versus cabozantinib or vandetanib (C/V) in advanced,\nkinase inhibitor-naïve, RET-mutant medullary thyroid cancer (MTC). These data\nhave supported global approvals of Retevmo in this treatment setting.\n\nVerzenio (abemaciclib; CDK4/6 inhibitor): A rapid oral presentation on\noverall survival data from the Phase 3 postMONARCH trial of abemaciclib plus\nfulvestrant in HR-positive, HER2-negative advanced breast cancer following\nprogression on a prior CDK4/6 inhibitor and endocrine therapy. These data\nsupport the abemaciclib plus imlunestrant results in the EMBER-3 trial and add\nto the evidence-based practice of switching endocrine therapy and CDK4/6\ninhibitor at progression in metastatic breast cancer.\n\n\"Lilly's presentations at ESMO reflect both the breadth of our oncology\nportfolio and the focus behind it: following compelling science wherever it\nhas the potential to change care,\" said Jacob Van Naarden, executive vice\npresident and president of Lilly Oncology. \"We're especially encouraged by the\ndata we're sharing for sofetabart mipitecan in platinum-sensitive ovarian\ncancer, which build on what we've seen with this medicine in\nplatinum-resistant disease and mark a critical step forward as we advance the\nongoing Phase 3 FRAmework-01 study across both settings. Our updated\nfirst-line data for olomorasib in KRAS G12C-mutant lung cancer are very\npromising, with clinical activity and a safety profile consistent with earlier\nfindings, which reinforce the importance of targeted therapy for patients from\nthe outset of their treatment journey. Alongside new data in thyroid and\nbreast cancers, these presentations represent meaningful momentum toward\nimproving care for people with cancer.\"\n\nA full list of abstract titles and viewing details are listed below:\n Abstract Title                              Author           Presentation      Session Title       Session Date/Time\n                                                              Type/#\n(CET)\n Sofe-M (sofetabart mipitecan; investigational ADC targeting FRα):\n Model-informed Phase 3 dose                 Jean-            Poster            Poster display      Friday, October 23\n selection for antibody-drug conjugate       Sebastien        #1016P            session\n15:15-16:00\n (ADC) sofetabart mipitecan (Sofe-M):        Frenel\n First prospective application of a\n clinical utility index (CUI)\n Efficacy and safety                         Chrisann Kyi     Rapid oral        Rapid oral 2:       Saturday, October 24\n of sofetabart mipitecan (Sofe-M), a                          #1246RO           Gynecological\n8:30-10:00\n folate receptor alpha (FRα) targeting                                          cancers\n antibody drug conjugate (ADC), plus\n bevacizumab in recurrent platinum\n sensitive ovarian cancer (PSOC)\n Sofetabart mipitecan (Sofe-M) in            Ana Oaknin       Poster            Poster display      Monday, October 26\n patients ≥65 y with platinum-resistant                       #1288P            session\n12:00-12:45\n and -sensitive ovarian cancer\n (PROC/PSOC) from the first-in-human\n phase 1 study\n Olomorasib (investigational KRAS G12C inhibitor)\n First-line (1L) olomorasib +                Marcelo V.       Rapid oral        Rapid oral 2:       Sunday,\n chemoimmunotherapy (Chemo-IO) in            Negrao           #2652RO           NSCLC, metastatic\nOctober 25\n KRAS G12C-mutant NSCLC: Updated\n8:30-10:00\n results from the LOXO-RAS-20001 and\n SUNRAY-01 trials\n First-line (1L) olomorasib +                Melissa L.       Poster            Poster display      Monday, October 26\n pembrolizumab in KRAS G12C-mutant           Johnson          #2683P            session\n12:00-12:45\n NSCLC: Updated results from LOXO-\n RAS-20001 and SUNRAY-01\n Retevmo (selpercatinib; RET kinase inhibitor)\n Updated results of randomized Phase         Jaume            Proffered paper   Proffered paper:    Monday, October 26\n 3 study of selpercatinib vs                 Capdevila        #4208O            NETs and\n10:15-11:45\n cabozantinib or vandetanib (C/V) in                                            endocrine tumors\n advanced, kinase inhibitor-naïve, RET-\n mutant medullary thyroid cancer\n (MTC)\n Verzenio (abemaciclib; CDK4/6 inhibitor)\n Association of p27 V109G SNP zygosity       Miguel           Poster            Poster display      Friday, October 23\n with outcomes                               Quintela-        #4498P            session\n15:15-16:00\n and abemaciclib treatment effect in         Fandino\n HR+, HER2– high-risk early breast\n cancer: results from monarchE\n Overall survival from the Phase             Kevin Kalinsky   Rapid oral        Rapid oral 1:       Saturday, October 24\n 3 postMONARCH trial of abemaciclib +                         #1RO              Breast cancer,\n10:15-11:45\n fulvestrant vs placebo + fulvestrant for                                       advanced stage\n HR+, HER2– advanced breast cancer\n following progression on a prior\n CDK4/6 inhibitor + endocrine therapy\n Three-month persistence and                 Isabel Blancas   ePoster           ePoster session     Friday, October 23\n adherence to adjuvant abemaciclib in        López-Barajas    #1933eP\n8:00\n high-risk HR+, HER2– early breast\n cancer: real world data from ABSIDE-S\n Treatment persistence and clinical          Hitomi Sakai     ePoster           ePoster session     Friday, October 23\n characteristics in patients with HR+,                        #615eP\n8:00\n HER2–, high-risk early breast cancer\n (EBC) treated with abemaciclib: A\n multi-country real-world study\n\nFor more information on Lilly's oncology pipeline, click here\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=2508125402&u=https%3A%2F%2Fwww.lillyoncologypipeline.com%2F%3Fgad_source%3D1%26gbraid%3D0AAAAA9Rru3oHs3Sy4g3vfexgNREGpgGpf%26gclid%3DCjwKCAjwvr--BhB5EiwAd5YbXq2ma8vcD6tpqZe5QErTeWllvIlp7wr7QAoGNMOl8fnCUoDfZ1ONeRoCtQgQAvD_BwE&a=here)\n.\n\nAbout Sofetabart Mipitecan\nSofetabart mipitecan (Sofe-M; LY4170156) is composed of an Fc-silent, folate\nreceptor alpha (FRα) specific humanized monoclonal antibody linked to\nexatecan, a topoisomerase I inhibitor, via a proprietary cleavable\npolysarcosine linker (PSARlink). Sofe-M was designed to target FRα across\nall expression levels with an improved therapeutic index. FRα is a\ncell-surface glycoprotein encoded by the gene FOLR1 that binds to the\nessential nutrients folic acid and reduced folates, bringing them into cells\nto facilitate cell division and growth.(1,2) FRα is overexpressed in many\nsolid tumors such as ovarian and endometrial cancers.(1,3,4 )Sofe-M has\nreceived Breakthrough Therapy Designation from the U.S. Food and Drug\nAdministration for platinum-resistant ovarian cancer (PROC) and is currently\nbeing evaluated in the Phase 3 FRAmework-01 trial. The study is being\nconducted in partnership with the European Network for Gynaecological\nOncological Trial groups (ENGOT – lead groups GINECO/NOGGO e.V.), the GOG\nFoundation (GOG), and the Asia-Pacific Gynecologic Oncology Trials Group\n(APGOT).\n\nAbout Olomorasib\nOlomorasib (LY3537982) is an investigational, oral, potent, and highly\nselective second-generation inhibitor of the KRAS G12C protein. KRAS is the\nmost common oncogene across all tumor types, and KRAS G12C mutations occur in\n13% of patients with non-small cell lung cancer (NSCLC), and 1–3% of\npatients with other solid tumors.(5 )Olomorasib is a highly potent covalent\ninhibitor with potential for greater than 90% target occupancy, which may\nallow for safer combinations with less toxicity.(6)\n\nOlomorasib is currently being studied in KRAS G12C-mutant cancers in\ncombination with pembrolizumab with or without chemotherapy for first-line\ntreatment of advanced NSCLC, in combination with immunotherapy for the\ntreatment of resected and unresectable NSCLC, and as monotherapy and in\ncombinations in other advanced solid tumors (NCT06119581, NCT06890598, and\nNCT04956640).\n\nAbout Retevmo\nRetevmo (selpercatinib, formerly known as LOXO-292)\n(pronounced reh-TEHV-moh) is a highly selective and potent\nRET kinase inhibitor with central nervous system (CNS)\nactivity. Retevmo may affect both tumor cells and healthy cells, which can\nresult in side effects. RET-driver alterations are predominantly mutually\nexclusive from other oncogenic drivers. Retevmo is a U.S. FDA-approved\noral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or\n≥50 kg, respectively), taken twice daily until disease progression or\nunacceptable toxicity.(7)\n\nINDICATIONS FOR RETEVMO (selpercatinib)\nRETEVMO is a kinase inhibitor indicated for the treatment of:\n\n * Adult and pediatric patients 2 years of age and older with advanced or\nmetastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by\nan FDA-approved test, who require systemic therapy\nIMPORTANT SAFETY INFORMATION FOR RETEVMO (selpercatinib)\n\nHepatotoxicity: Serious hepatic adverse reactions occurred in 4.6% of patients\ntreated with Retevmo. Increased aspartate aminotransferase (AST) occurred in\n62% of patients, including Grade 3 or 4 events in 11% and increased alanine\naminotransferase (ALT) occurred in 58% of patients, including Grade 3 or 4\nevents in 13%. Monitor ALT and AST prior to initiating Retevmo, every 2 weeks\nduring the first 3 months, then monthly thereafter and as clinically\nindicated. Withhold, reduce dose, or permanently discontinue Retevmo based on\nseverity.\n\nSevere, life-threatening, and fatal interstitial lung disease\n(ILD)/pneumonitis can occur in patients treated with Retevmo. ILD/pneumonitis\noccurred in 3% of patients who received Retevmo, including 0.3% with Grade 3\nor 4 events, and 0.2% with fatal reactions. Monitor for pulmonary symptoms\nindicative of ILD/pneumonitis. Withhold Retevmo and promptly investigate for\nILD in any patient who presents with acute or worsening of respiratory\nsymptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever).\nWithhold, reduce dose, or permanently discontinue Retevmo based on severity of\nconfirmed ILD.\n\nHypertension occurred in 43% of patients, including Grade 3 hypertension in\n20% and Grade 4 in one (0.1%) patient. Overall, 6.4% had their dose\ninterrupted, 1.5% had their dose reduced, and 0.2% discontinued Retevmo for\nhypertension. Treatment-emergent hypertension was most commonly managed with\nanti-hypertension medications. Do not initiate Retevmo in patients with\nuncontrolled hypertension. Optimize blood pressure prior to initiating\nRetevmo. Monitor blood pressure after 1 week, at least monthly thereafter, and\nas clinically indicated. Initiate or adjust anti-hypertensive therapy as\nappropriate. Withhold, reduce dose, or permanently discontinue Retevmo based\non severity.\n\nRetevmo can cause concentration-dependent QT interval prolongation. An\nincrease in QTcF interval to >500 ms was measured in 8% of patients and an\nincrease in the QTcF interval of at least 60 ms over baseline was measured in\n22% of patients. Retevmo has not been studied in patients with clinically\nsignificant active cardiovascular disease or recent myocardial infarction.\nMonitor patients who are at significant risk of developing QTc prolongation,\nincluding patients with known long QT syndromes, clinically significant\nbradyarrhythmias, and severe or uncontrolled heart failure. Assess QT\ninterval, electrolytes, and thyroid-stimulating hormone (TSH) at baseline and\nperiodically during treatment, adjusting frequency based upon risk factors\nincluding diarrhea.\n\nCorrect hypokalemia, hypomagnesemia, and hypocalcemia prior to initiating\nRetevmo and during treatment. Monitor the QT interval more frequently when\nRetevmo is concomitantly administered with strong and moderate CYP3A\ninhibitors or drugs known to prolong QTc interval. Withhold and dose reduce or\npermanently discontinue Retevmo based on the severity.\n\nSerious, including fatal, hemorrhagic events can occur with Retevmo. Grade\n≥3 hemorrhagic events occurred in 4.3% of patients treated with Retevmo\nincluding 4 (0.5%) patients with fatal hemorrhagic events, including cerebral\nhemorrhage (n=2), tracheostomy site hemorrhage and hemoptysis (1 each).\nPermanently discontinue Retevmo in patients with severe or life-threatening\nhemorrhage.\n\nRetevmo can cause hypersensitivity, including severe skin reactions such as\nStevens-Johnson Syndrome. All grade hypersensitivity occurred in 6% of\npatients receiving Retevmo, including Grade 3 in 2%. The median time to onset\nwas 1.9 weeks (range: 5 days to 6.5 years). Signs and symptoms of\nhypersensitivity included fever, rash and arthralgias or myalgias with\nconcurrent decreased platelets or transaminitis. Stevens-Johnson Syndrome has\nbeen observed in the post-marketing setting. Discontinue Retevmo in patients\nwith Stevens-Johnson Syndrome. If hypersensitivity occurs, withhold Retevmo\nand begin corticosteroids at a dose of 1 mg/kg prednisone (or equivalent).\nUpon resolution of the event, resume Retevmo at a reduced dose and increase\nthe dose of Retevmo by 1 dose level each week as tolerated until reaching the\ndose taken prior to onset of hypersensitivity. Continue steroids until patient\nreaches target dose and then taper. Permanently discontinue Retevmo for\nrecurrent hypersensitivity.\n\nTumor lysis syndrome (TLS) occurred in 0.9% of patients with medullary thyroid\ncarcinoma and 0.3% of patients with non-small cell lung cancer receiving\nRetevmo. Patients may be at risk of TLS if they have rapidly growing tumors, a\nhigh tumor burden, renal dysfunction, or dehydration. Closely monitor patients\nat risk, consider appropriate prophylaxis including hydration, and treat as\nclinically indicated.\n\nImpaired wound healing can occur in patients who receive drugs that inhibit\nthe vascular endothelial growth factor (VEGF) signaling pathway. Therefore,\nRetevmo has the potential to adversely affect wound healing. Withhold Retevmo\nfor at least 7 days prior to elective surgery. Do not administer for at least\n2 weeks following major surgery and until adequate wound healing. The safety\nof resumption of Retevmo after resolution of wound healing complications has\nnot been established.\n\nRetevmo can cause hypothyroidism. Hypothyroidism occurred in 15% of patients\ntreated with Retevmo; all reactions were Grade 1 or 2. Hypothyroidism occurred\nin 15% of patients (59/390) with thyroid cancer and 14% of patients (65/467)\nwith other solid tumors including NSCLC. Monitor thyroid function before\ntreatment with Retevmo and periodically during treatment. Treat with thyroid\nhormone replacement as clinically indicated. Withhold Retevmo until clinically\nstable or permanently discontinue Retevmo based on severity.\n\nBased on data from animal reproduction studies and its mechanism of action,\nRetevmo can cause fetal harm when administered to a pregnant woman.\nAdministration of selpercatinib to pregnant rats during organogenesis at\nmaternal exposures that were approximately equal to those observed at the\nrecommended human dose of 160 mg twice daily resulted in embryolethality and\nmalformations. Advise pregnant women and females of reproductive potential of\nthe potential risk to a fetus. Advise females of reproductive potential and\nmales with female partners of reproductive potential to use effective\ncontraception during treatment with Retevmo and for 1 week after the last\ndose. There are no data on the presence of selpercatinib or its metabolites in\nhuman milk or on their effects on the breastfed child or on milk production.\nBecause of the potential for serious adverse reactions in breastfed children,\nadvise women not to breastfeed during treatment with Retevmo and for 1 week\nafter the last dose.\n\nSlipped capital femoral epiphysis/slipped upper femoral epiphysis in pediatric\npatients (SCFE/SUFE) occurred in 1 adolescent (2.8% of 36 patients) receiving\nRetevmo in LIBRETTO-121 and 1 adolescent patient (0.5% of 193 patients)\nreceiving Retevmo in LIBRETTO-531. Monitor patients for symptoms indicative of\nSCFE/SUFE and treat as medically and surgically appropriate.\n\nSevere adverse reactions (Grade 3-4) occurring in ≥20% of patients who\nreceived Retevmo in LIBRETTO-001 were hypertension (20%), diarrhea (6.2%),\nprolonged QT interval (5%), fatigue (4.7%), musculoskeletal pain (4.1%),\ndyspnea (4.1%), hemorrhage (3.9%), abdominal pain (3.5%), vomiting (2.9%),\nurinary tract infection (2.2%), nausea (1.9%), headache (1.8%), edema (1.3%),\ndecreased appetite (0.9%), constipation (0.8%), rash (0.8%), and dizziness\n(0.5%).\n\nSevere adverse reactions (Grade 3-4) occurring in ≥15% of patients who\nreceived Retevmo in LIBRETTO-121 were increased weight (11%), vomiting (8%),\nconstipation (6%), diarrhea (2.8%), nausea (2.8%), upper respiratory tract\ninfection (2.8%), and urinary tract infection (2.8%).\n\nSevere adverse reactions (Grade 3-4) occurring in ≥15% of patients who\nreceived Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431\nwere hypertension (20% vs 3.1%), electrocardiogram QT prolonged (9% vs 0%),\nfatigue (3.2% vs 5%), edema (2.5% vs 0%), rash (1.9% vs 1.0%), diarrhea (1.3%\nvs 2.0%), abdominal pain (0.6% vs 2.0%), pyrexia (0.6% vs 0%), COVID19\ninfection (0.6% vs 0%), constipation (0% vs 1.0%), nausea (0% vs 1.0%),\nvomiting (0% vs 1.0%), and decreased appetite (0% vs 2.0%).\n\nSevere adverse reactions (Grade 3-4) occurring in ≥10% of patients who\nreceived Retevmo in LIBRETTO-531 were (Retevmo vs cabozantinib / vandetanib)\nhypertension (19% vs 18%), electrocardiogram QT prolonged (4.7% vs 2.1%),\nfatigue (4.1% vs 9%), diarrhea (3.1% vs 8%), rash (1.6% vs 4.1%), pyrexia\n(1.0% vs 0%), nausea (1.0% vs 5%), dry mouth (0.5% vs 1.0%), abdominal pain\n(0.5% vs 2.1%), stomatitis (0.5% vs 13%), headache (0.5% vs 0%), and decreased\nappetite (0.5% vs 5%).\n\nSerious adverse reactions occurred in 58% of patients who received Retevmo in\nLIBRETTO-001. The most frequently reported serious adverse reactions (in ≥2%\nof patients) were pneumonia, hemorrhage, abdominal pain, dyspnea, pleural\neffusion, sepsis, musculoskeletal pain, hyponatremia, vomiting, diarrhea, and\nincreased blood creatinine. Fatal adverse reactions occurred in 3% of patients\nin LIBRETTO-001; fatal adverse reactions included sepsis (n=6), respiratory\nfailure (n=5), hemorrhage (n=4), pneumonia (n=4), cardiac arrest (n=3),\npneumonitis (n=2), cardiac failure (n=2), sudden death (n=1), cerebral\ninfarction (n=1), and dyspnea (n=1).\n\nSerious adverse reactions occurred in 42% of patients who received Retevmo in\nLIBRETTO-121. Serious adverse reactions occurring in more than 1 patient were\nvomiting and fracture (2 patients each).\n\nSerious adverse reactions occurred in 35% of patients who received Retevmo in\nLIBRETTO-431. The most frequently reported serious adverse reactions (≥2%\nof patients) were pleural effusion and abnormal hepatic function. Fatal\nadverse reactions occurred in 4.4% of patients who received Retevmo in\nLIBRETTO-431; fatal adverse reactions included myocardial infarction (n=2),\nrespiratory failure (n=2), cardiac arrest, malnutrition, and sudden death (n=1\neach).\n\nSerious adverse reactions occurred in 22% of patients who received Retevmo in\nLIBRETTO-531. The most frequent serious adverse reactions were pneumonia and\npyrexia (n=3 each), and hypertension and urinary tract infection (n=2 each).\nFatal adverse reactions occurred in 2.1% of patients who received Retevmo in\nLIBRETTO-531; fatal adverse reactions included COVID19, diabetic ketoacidosis,\nmultiple organ dysfunction syndrome, and sudden death (n=1 each).\n\nCommon adverse reactions (all grades) occurring in ≥20% of patients who\nreceived Retevmo in LIBRETTO-001 were musculoskeletal pain (59%), edema\n(53%), diarrhea (52%), fatigue (49%), dry mouth (44%), hypertension (43%),\nabdominal pain (39%), rash (38%), nausea (36%), constipation (35%), cough\n(30%), headache (30%), vomiting (29%), dyspnea (28%), hemorrhage (26%),\ndecreased appetite (23%), dizziness (22%), prolonged QT interval (21%), and\nurinary tract infection (20%).\n\nCommon adverse reactions (all grades) occurring in ≥15% of patients who\nreceived Retevmo in LIBRETTO-121 were musculoskeletal pain (58%), diarrhea\n(47%), nausea (42%), hemorrhage (39%), pyrexia (39%), abdominal pain (36%),\nheadache (33%), vomiting (31%), fatigue (31%), cough (31%), rash (28%),\ncoronavirus infection (28%), upper respiratory tract infection (28%), edema\n(25%), constipation (22%), oropharyngeal pain (22%), hypothyroidism (22%),\nurinary tract infection (19%), and increased weight (19%).\n\nCommon adverse reactions (all grades) occurring in ≥15% of patients who\nreceived Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431\nwere hypertension (48% vs 7%), diarrhea (44% vs 24%), edema (41% vs 28%), dry\nmouth (39% vs 6%), rash (33% vs 30%), fatigue (32% vs 50%), abdominal pain\n(25% vs 19%), musculoskeletal pain (25% vs 28%), constipation (22% vs 40%),\nelectrocardiogram QT prolonged (20% vs 1.0%), COVID19 infection (19% vs 18%),\nstomatitis (18% vs 16%), decreased appetite (17% vs 34%), nausea (13% vs 44%),\nvomiting (13% vs 23%), and pyrexia (13% vs 23%).\n\nCommon adverse reactions (all grades) occurring in ≥10% of patients who\nreceived Retevmo in LIBRETTO-531 (Retevmo vs cabozantinib / vandetanib) were\nhypertension (43% vs 41%), edema (33% vs 5%), dry mouth (32% vs 10%), fatigue\n(28% vs 47%), diarrhea (26% vs 61%), headache (23% vs 21%), rash (19% vs 27%),\nabdominal pain (18% vs 21%), constipation (16% vs 12%), erectile dysfunction\n(16% vs 0%), stomatitis (14% vs 42%), electrocardiogram QT prolonged (14% vs\n13%), pyrexia (12% vs 2.1%), decreased appetite (12% vs 28%), hypothyroidism\n(11% vs 21%), and nausea (10% vs 32%).\n\nLaboratory abnormalities (all grades ≥20%; Grade 3-4) worsening from\nbaseline in patients who received Retevmo in LIBRETTO-001, were increased AST\n(62%; 11%), decreased calcium (61%; 7%), decreased albumin (61%; 3.6%),\nincreased ALT (58%; 13%), increased glucose (56%; 4.0%), decreased lymphocytes\n(56%; 22%), increased creatinine (51%; 3.6%), decreased sodium (49%; 13%),\nincreased alkaline phosphatase (43%; 4.4%), decreased platelets (41%; 4.0%),\nincreased potassium (39%; 3.5%), decreased glucose (39%; 1.5%), increased\ntotal cholesterol (37%; 1.7%), decreased magnesium (37%; 0.7%), decreased\nhemoglobin (36%; 4.1%), increased bilirubin (32%; 2.9%), decreased neutrophils\n(27%; 3.8%), and decreased phosphate (25%; 5%).\n\nLaboratory abnormalities (all grades ≥15%; Grade 3-4) worsening from\nbaseline in patients who received Retevmo in LIBRETTO-121 were decreased\ncalcium (61%; 11%), increased ALT (58%; 8%), decreased albumin (53%; 0%),\nincreased alkaline phosphatase (50%; 0%), increased AST (50%; 2.8%), increased\nbilirubin (31%; 2.8%), increased cholesterol (28%, 0%), decreased magnesium\n(28%; 6%), increased potassium (28%; 2.8%), increased creatinine (19%, 2.8%),\ndecreased potassium (19%, 6%), decreased sodium (17%, 0%), decreased\nneutrophils (40%; 8%), decreased hemoglobin (36%; 11%), increased hemoglobin\n(33%, 2.8%), decreased platelets (28%; 2.8%), and decreased lymphocytes (28%;\n14%).\n\nLaboratory abnormalities (all grades ≥20%; Grade 3-4) worsening from\nbaseline in patients who received Retevmo or chemotherapy with or without\npembrolizumab in LIBRETTO-431 were increased ALT (81%; 21% vs 63%; 4.1%),\nincreased AST (77%; 10% vs 46%; 0%), decreased calcium (53%; 1.9% vs 24%;\n1.0%), decreased platelets (53%; 3.2% vs 39%; 5%), decreased lymphocytes (53%;\n8% vs 64%; 15%), decreased neutrophils (53%; 2.0% vs 58%; 11%), increased\nbilirubin (52%; 1.3% vs 9%; 0%), increased alkaline phosphatase (35%; 1.3% vs\n22%; 0%), decreased sodium (31%; 3.2% vs 41%; 2.1%), decreased albumin (25%;\n0% vs 5%; 0%), increased blood creatinine (23%; 0% vs 21%; 0%), decreased\nhemoglobin (21%; 0% vs 91%; 5%), decreased potassium (17%; 1.3% vs 15%; 1.0%),\nand decreased magnesium (16%; 0.6% vs 8%; 0%).\n\nLaboratory abnormalities (all grades ≥5%; Grade 3-4) worsening from baseline\nin patients who received Retevmo in LIBRETTO-531 (Retevmo vs cabozantinib /\nvandetanib) were decreased calcium (55%; 5% vs 62%; 11%), increased ALT (53%;\n16% vs 72%; 7%), increased AST (47%; 5% vs 68%; 3.2%), decreased lymphocytes\n(41%; 18% vs 36%; 13%), increased alkaline phosphatase (37%; 6% vs 28%, 5%),\nincreased bilirubin (32%; 1.1% vs 30%; 3.2%), decreased neutrophils (33%; 14%\nvs 42%; 19%), decreased platelets (28%; 1.1% vs 34%; 1.1%), increased\ncreatinine (27%; 6% vs 16%; 8%), decreased sodium (20%; 3.2% vs 16%; 0%),\ndecreased hemoglobin (18%; 2.1% vs 23%; 2.1%), decreased albumin (11%; 1.1% vs\n7%; 0%), decreased magnesium (9%; 3.3% vs 26%; 9%), and decreased potassium\n(8%; 0% vs 22%; 4.4%).\n\nConcomitant use of acid-reducing agents decreases selpercatinib plasma\nconcentrations which may reduce Retevmo anti-tumor activity. Avoid concomitant\nuse of proton-pump inhibitors (PPIs), histamine-2 (H2) receptor antagonists,\nand locally acting antacids with Retevmo. If coadministration cannot be\navoided, take Retevmo with food (with a PPI) or modify its administration time\n(with a H2 receptor antagonist or a locally acting antacid).\n\nConcomitant use of strong and moderate CYP3A inhibitors increases\nselpercatinib plasma concentrations which may increase the risk of Retevmo\nadverse reactions including QTc interval prolongation. Avoid concomitant use\nof strong and moderate CYP3A inhibitors with Retevmo. If concomitant use of a\nstrong or moderate CYP3A inhibitor cannot be avoided, reduce the Retevmo\ndosage as recommended and monitor the QT interval with ECGs more frequently.\n\nConcomitant use of strong and moderate CYP3A inducers decreases selpercatinib\nplasma concentrations which may reduce Retevmo anti-tumor activity. Avoid\ncoadministration of Retevmo with strong and moderate CYP3A inducers.\n\nConcomitant use of Retevmo with CYP2C8 and CYP3A substrates increases their\nplasma concentrations which may increase the risk of adverse reactions related\nto these substrates. Avoid coadministration of Retevmo with CYP2C8 and CYP3A\nsubstrates where minimal concentration changes may lead to increased adverse\nreactions. If coadministration cannot be avoided, follow recommendations for\nCYP2C8 and CYP3A substrates provided in their approved product labeling.\n\nRetevmo is a P-glycoprotein (P-gp) and BCRP inhibitor. Concomitant use of\nRetevmo with P-gp or BCRP substrates increases their plasma concentrations,\nwhich may increase the risk of adverse reactions related to these substrates.\nAvoid coadministration of Retevmo with P-gp or BCRP substrates where minimal\nconcentration changes may lead to increased adverse reactions. If\ncoadministration cannot be avoided, follow recommendations for P-gp and BCRP\nsubstrates provided in their approved product labeling.\n\nThe safety and effectiveness of Retevmo have not been established in pediatric\npatients less than 2 years of age. The safety and effectiveness of Retevmo\nhave been established in pediatric patients aged 2 years and older for the\ntreatment of advanced or metastatic medullary thyroid cancer (MTC) with a RET\nmutation who require systemic therapy, advanced or metastatic thyroid cancer\nwith a RET gene fusion who require systemic therapy and are radioactive\niodine-refractory (if radioactive iodine is appropriate), and locally advanced\nor metastatic solid tumors with a RET gene fusion that have progressed on or\nfollowing prior systemic treatment or who have no satisfactory alternative\ntreatment options.\n\nMonitor open growth plates in pediatric patients. Consider interrupting or\ndiscontinuing Retevmo if abnormalities occur.\n\nNo dosage modification is recommended for patients with mild to severe renal\nimpairment (estimated Glomerular Filtration Rate [eGFR] ≥15 to 89 mL/min,\nestimated by Modification of Diet in Renal Disease [MDRD] equation). A\nrecommended dosage has not been established for patients with end-stage renal\ndisease.\n\nReduce the dose when administering Retevmo to patients with severe hepatic\nimpairment (total bilirubin greater than 3 to 10 times upper limit of normal\n[ULN] and any AST). No dosage modification is recommended for patients with\nmild or moderate hepatic impairment. Monitor for Retevmo-related adverse\nreactions in patients with hepatic impairment.\n\nRetevmo (selpercatinib) is available as 40 mg and 80 mg capsules, and 40 mg,\n80 mg, 120 mg, and 160 mg tablets.\n\nSE HCP ISI All_JUL2026\n\nPlease see full Prescribing Information\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=1731664991&u=https%3A%2F%2Fpi.lilly.com%2Fus%2Fretevmo-uspi.pdf&a=Prescribing+Information)\nand Instructions for Use\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=725668258&u=http%3A%2F%2Fuspl.lilly.com%2Fretevmo%2Fretevmo.html%3Fs%3Dug0&a=Instructions+for+Use)\nfor Retevmo.\n\nAbout Verzenio (abemaciclib)\nVerzenio (abemaciclib) is approved to treat people with certain HR+, HER2–\nbreast cancers in the adjuvant and advanced or metastatic settings. Verzenio\nis an oral tablet taken twice daily and available in strengths of 50 mg, 100\nmg, 150 mg, and 200 mg. Discovered and developed by Lilly researchers,\nVerzenio was first approved in 2017 and is authorized for use in more than 90\ncountries around the world. For full details on indicated uses of Verzenio in\nHR+, HER2– breast cancer, please see full Prescribing Information\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=2600874321&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4777053-1%26h%3D2587940306%26u%3Dhttps%253A%252F%252Fuspl.lilly.com%252Fverzenio%252Fverzenio.html%253Fs%253Dpi%26a%3DPrescribing%2BInformation%252C&a=Prescribing+Information)\n, available at www.Verzenio.com\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=841025049&u=https%3A%2F%2Fverzenio.lilly.com%2F%3Fredirect-referrer%3Dhttps%253A%252F%252Fword-edit.officeapps.live.com%252F&a=www.Verzenio.com)\n.\n\nINDICATIONS FOR VERZENIO\n\nVerzenio (abemaciclib) is a kinase inhibitor indicated(8,9):\n\n * in combination with endocrine therapy (tamoxifen or an aromatase inhibitor)\nfor the adjuvant treatment of adults with hormone receptor (HR)-positive,\nhuman epidermal growth factor receptor 2 (HER2)-negative, node-positive, early\nbreast cancer at high risk of recurrence.\n * in combination with an aromatase inhibitor as initial endocrine-based therapy\nfor the treatment of adults with HR-positive, HER2-negative advanced or\nmetastatic breast cancer.\n * in combination with fulvestrant for the treatment of adults with HR-positive,\nHER2-negative advanced or metastatic breast cancer with disease progression\nfollowing endocrine therapy.\n * in combination with Inluriyo for the treatment of adults with estrogen\nreceptor (ER)-positive, HER2-negative, estrogen receptor-1 (ESR1)-mutated\nadvanced or metastatic breast cancer, as detected by an FDA-authorized test,\nwith disease progression following at least one line of endocrine therapy.\n * as monotherapy for the treatment of adults with HR-positive, HER2-negative\nadvanced or metastatic breast cancer with disease progression following\nendocrine therapy and prior chemotherapy in the metastatic setting.\nIMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib)\nSevere diarrhea associated with dehydration and infection occurred in\npatients treated with Verzenio. Across five clinical trials in 3899 patients,\ndiarrhea occurred in 81% to 90% of patients who received Verzenio. Grade 3\ndiarrhea occurred in 8% to 20% of patients receiving Verzenio. Most patients\nexperienced diarrhea during the first month of Verzenio treatment. The median\ntime to onset of the first diarrhea event ranged from 6 to 8 days; and the\nmedian duration of Grade 2 and Grade 3 diarrhea ranged from 6 to 11 days and 5\nto 8 days, respectively. Across trials, 19% to 26% of patients with diarrhea\nrequired a Verzenio dose interruption and 13% to 23% required a dose\nreduction.\n\nInstruct patients to start antidiarrheal therapy such as loperamide at the\nfirst sign of loose stools, increase oral fluids, and notify their healthcare\nprovider for further instructions and appropriate follow-up. For Grade 3 or 4\ndiarrhea, or diarrhea that requires hospitalization, withhold Verzenio until\nresolution to ≤Grade 1, and then resume Verzenio at the next lower dose.\n\nNeutropenia, including febrile neutropenia and fatal neutropenic sepsis,\noccurred in patients treated with Verzenio. Across five clinical trials in\n3899 patients, neutropenia occurred in 37% to 51% of patients receiving\nVerzenio. A Grade ≥3 decrease in neutrophil count (based on laboratory\nfindings) occurred in 19% to 32% of patients receiving Verzenio.\n\nAcross trials, the median time to first episode of Grade ≥3 neutropenia\nranged from 29 days to 34 days, and the median duration of Grade ≥3\nneutropenia ranged from 10 days to 16 days.\n\nFebrile neutropenia has been reported in <1% of patients exposed to\nVerzenio across trials. Two deaths due to neutropenic sepsis were observed in\nMONARCH 2. Inform patients to promptly report any episodes of fever to their\nhealthcare provider.\n\nMonitor complete blood counts prior to the start of Verzenio therapy, every 2\nweeks for the first 2 months, monthly for the next 2 months, and as clinically\nindicated. Dose interruption, dose reduction, or delay in starting treatment\ncycles is recommended for patients who develop Grade 3 or 4 neutropenia.\n\nSevere, life-threatening, or fatal interstitial lung disease (ILD) or\npneumonitis can occur in patients treated with Verzenio and other CDK4/6\ninhibitors. In Verzenio-treated patients in early breast cancer (monarchE,\nN=2791), 3% of patients experienced ILD or pneumonitis of any grade: 0.4% were\nGrade 3 or 4 and there was one fatality (0.1%). In Verzenio-treated patients\nin advanced or metastatic breast cancer (N=1108) (MONARCH 1, MONARCH 2,\nMONARCH 3, EMBER-3), 3.2% of Verzenio-treated patients had ILD or pneumonitis\nof any grade: 0.5% had Grade 3 or 4, and 0.5% had fatal outcomes. Additional\ncases of ILD or pneumonitis have been observed in the postmarketing setting,\nwith fatalities reported.\n\nMonitor patients for pulmonary symptoms indicative of ILD or pneumonitis.\nSymptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on\nradiologic exams. Infectious, neoplastic, and other causes for such symptoms\nshould be excluded by means of appropriate investigations.\n\nWithhold or reduce dose for patients who develop persistent or recurrent Grade\n2 ILD or pneumonitis. Permanently discontinue VERZENIO in all patients with\nGrade 3 or 4 ILD or pneumonitis.\n\nGrade ≥3 increases in alanine aminotransferase (ALT) (2% to 6%) and\naspartate aminotransferase (AST) (2% to 3%) were reported in patients\nreceiving Verzenio.\n\nAcross four clinical trials in 3767 patients (monarchE, MONARCH 2, MONARCH 3,\nEMBER-3), the median time to onset of Grade ≥3 ALT increases ranged from 57\nto 87 days and the median time to resolution to Grade <3 was 13 to 14 days.\nThe median time to onset of Grade ≥3 AST increases ranged from 71 to 185\ndays and the median time to resolution to Grade <3 ranged from 11 to 15\ndays.\n\nMonitor liver function tests (LFTs) prior to the start of VERZENIO therapy,\nevery 2 weeks for the first 2 months, monthly for the next 2 months, and as\nclinically indicated. Dose interruption, dose reduction, dose discontinuation,\nor delay in starting treatment cycles is recommended for patients who develop\npersistent or recurrent Grade 2, or any Grade 3 or Grade 4 hepatic\ntransaminase elevation.\n\nVenous thromboembolic events (VTE) were reported in 2% to 5% of patients\ntreated with Verzenio across four clinical trials in 3767 patients (monarchE,\nMONARCH 2, MONARCH 3, EMBER-3). VTE events included deep vein thrombosis,\npulmonary embolism, pelvic venous thrombosis, cerebral venous sinus\nthrombosis, subclavian and axillary vein thrombosis, inferior vena cava\nthrombosis, jugular vein thrombosis, peripheral vein thrombosis and\nsuperficial vein thrombosis. In clinical trials, deaths due to VTE occurred in\npatients treated with Verzenio.\n\nVerzenio has not been studied in patients with early breast cancer who had a\nhistory of VTE. Monitor patients for signs and symptoms of venous thrombosis\nand pulmonary embolism and treat as medically appropriate. Dose interruption\nis recommended for early breast cancer patients with any grade VTE event and\nfor advanced or metastatic breast cancer patients with a Grade 3 or 4 VTE\nevent.\n\nVerzenio can cause fetal harm when administered to a pregnant woman, based on\nfindings from animal studies and the mechanism of action. In animal\nreproduction studies, administration of abemaciclib to pregnant rats during\nthe period of organogenesis caused teratogenicity and decreased fetal weight\nat maternal exposures that were similar to the human clinical exposure based\non area under the curve (AUC) at the maximum recommended human dose.\n\nAdvise pregnant women of the potential risk to a fetus. Advise females of\nreproductive potential to use effective contraception during treatment with\nVerzenio and for 3 weeks after the last dose.\n\nVerzenio can increase serum creatinine without affecting renal function.\nThese increases were not associated with changes in glomerular function. In\nEMBER-3, creatinine increase occurred in 36% for all grades (Grade 3 or 4:\n1.1%) of patients who received Inluriyo in combination with Verzenio. During\nVerzenio treatment, use alternative measures that are not based on serum\ncreatinine to assess renal function such as BUN, cystatin C, or calculated\nGFR.\n\nThe most common adverse reactions (all grades, ≥10%) observed in monarchE\nfor Verzenio plus tamoxifen or an aromatase inhibitor vs tamoxifen or an\naromatase inhibitor, with a difference between arms of ≥2%, were diarrhea\n(84% vs 9%), infections (51% vs 39%), neutropenia (46% vs 6%), fatigue (41% vs\n18%), leukopenia (38% vs 7%), nausea (30% vs 9%), anemia (24% vs 4%), headache\n(20% vs 15%), vomiting (18% vs 4.6%), stomatitis (14% vs 5%), lymphopenia (14%\nvs 3%), thrombocytopenia (13% vs 2%), decreased appetite (12% vs 2.4%), ALT\nincreased (12% vs 6%), AST increased (12% vs 5%), dizziness (11% vs 7%), rash\n(11% vs 4.5%), and alopecia (11% vs 2.7%).\n\nThe most frequently reported ≥5% Grade 3 or 4 adverse reaction that\noccurred in the Verzenio arm vs the tamoxifen or an aromatase inhibitor arm of\nmonarchE were neutropenia (19.6% vs 1%), leukopenia (11% vs <1%), diarrhea\n(8% vs 0.2%), and lymphopenia (5% vs <1%).\n\nLab abnormalities (all grades; Grade 3 or 4) for monarchE in ≥10% for\nVerzenio plus tamoxifen or an aromatase inhibitor with a difference between\narms of ≥2% were increased serum creatinine (99% vs 91%; 0.5% vs <0.1%),\ndecreased white blood cells (89% vs 28%; 19.1% vs 1.1%), decreased neutrophil\ncount (84% vs 23%; 18.7% vs 1.9%), anemia (68% vs 17%; 1% vs .1%), decreased\nlymphocyte count (59% vs 24%; 13.2% vs 2.5%), decreased platelet count (37% vs\n10%; .9% vs .2%), increased ALT (37% vs 24%; 2.6% vs 1.2%), increased AST (31%\nvs 18%; 1.6% vs .9%), and hypokalemia (11% vs 3.8%; 1.3% vs 0.2%).\n\nThe most common adverse reactions (all grades, ≥10%) observed in MONARCH 3\nfor Verzenio plus anastrozole or letrozole vs anastrozole or letrozole, with a\ndifference between arms of ≥2%, were diarrhea (81% vs 30%), fatigue (40% vs\n32%), neutropenia (41% vs 2%), infections (39% vs 29%), nausea (39% vs 20%),\nabdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs 5%),\nalopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia (21% vs 2%),\ncreatinine increased (19% vs 4%), constipation (16% vs 12%), ALT increased\n(16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), pruritus (13% vs\n9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight\ndecreased (10% vs 3.1%), influenza-like illness (10% vs 8%), and\nthrombocytopenia (10% vs 2%).\n\nThe most frequently reported ≥5% Grade 3 or 4 adverse reactions that\noccurred in the Verzenio arm vs the placebo arm of MONARCH 3 were neutropenia\n(22% vs 1%), diarrhea (9% vs 1.2%), leukopenia (7% vs <1%)), increased ALT\n(6% vs 2%), and anemia (6% vs 1%).\n\nLab abnormalities (all grades; Grade 3 or 4) for MONARCH 3 in ≥10% for\nVerzenio plus anastrozole or letrozole with a difference between arms of ≥2%\nwere increased serum creatinine (98% vs 84%; 2.2% vs 0%), decreased white\nblood cells (82% vs 27%; 13% vs 0.6%), anemia (82% vs 28%; 1.6% vs 0%),\ndecreased neutrophil count (80% vs 21%; 21.9% vs 2.6%), decreased lymphocyte\ncount (53% vs 26%; 7.6% vs 1.9%), decreased platelet count (36% vs 12%; 1.9%\nvs 0.6%), increased ALT (48% vs 25%; 6.6% vs 1.9%), and increased AST (37% vs\n23%; 3.8% vs 0.6%).\n\nThe most common adverse reactions (all grades, ≥10%) observed in MONARCH 2\nfor Verzenio plus fulvestrant vs fulvestrant, with a difference between arms\nof ≥2%, were diarrhea (86% vs 25%), neutropenia (46% vs 4%), fatigue (46%\nvs 32%), nausea (45% vs 23%), infections (43% vs 25%), abdominal pain (35% vs\n16%), anemia (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs\n12%), vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 2.7%),\nthrombocytopenia (16% vs 3%), alopecia (16% vs 1.8%), stomatitis (15% vs 10%),\nALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), dizziness\n(12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 7%),\ncreatinine increased (12% vs <1%), rash (11% vs 4.5%), pyrexia (11% vs 6%),\nand weight decreased (10% vs 2.2%).\n\nThe most frequently reported ≥5% Grade 3 or 4 adverse reactions that\noccurred in the Verzenio arm vs the placebo arm of MONARCH 2 were neutropenia\n(25% vs 1%), diarrhea (13% vs 0.4%), leukopenia (9% vs 0%), anemia (7% vs 1%),\nand infections (5.7% vs 3.5%).\n\nLab abnormalities (all grades; Grade 3 or 4) for MONARCH 2 in ≥10% for\nVerzenio plus fulvestrant with a difference between arms of ≥2% were\nincreased serum creatinine (98% vs 74%; 1.2% vs 0%), decreased white blood\ncells (90% vs 33%; 23.7% vs .9%), decreased neutrophil count (87% vs 30%;\n32.5% vs 4.2%), anemia (84% vs 34%; 2.6% vs .5%), decreased lymphocyte count\n(63% vs 32%; 12.2% vs 1.8%), decreased platelet count (53% vs 15%; 2.1% vs\n0%), increased ALT (41% vs 32%; 4.6% vs 1.4%), and increased AST (37% vs 25%;\n3.9% vs 4.2%).\n\nThe most common adverse reactions (all grades, ≥10%) observed in MONARCH\n1 with Verzenio were diarrhea (90%), fatigue (65%), nausea (64%), decreased\nappetite (45%), abdominal pain (39%), neutropenia (37%), vomiting (35%),\ninfections (31%), anemia (25%), thrombocytopenia (20%), headache (20%), cough\n(19%), constipation (17%), leukopenia (17%), arthralgia (15%), dry mouth\n(14%), weight decreased (14%), stomatitis (14%), creatinine increased (13%),\nalopecia (12%), dysgeusia (12%), pyrexia (11%), dizziness (11%), and\ndehydration (10%).\n\nThe most frequently reported ≥5% Grade 3 or 4 adverse reactions from MONARCH\n1 with Verzenio were diarrhea (20%), neutropenia (24%), fatigue (13%), and\nleukopenia (5%).\n\nLab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 with Verzenio were\nincreased serum creatinine (99%; .8%), decreased white blood cells (91%; 28%),\ndecreased neutrophil count (88%; 26.6%), anemia (69%; 0%), decreased\nlymphocyte count (42%; 13.8%), decreased platelet count (41%; 2.3%), increased\nALT (31%; 3.1%), and increased AST (30%; 3.8%).\n\nSerious and Fatal Adverse Reactions for Inluriyo in combination with\nVerzenio: Serious adverse reactions occurred in 21% of patients who received\nInluriyo in combination with Verzenio. Serious adverse reactions in >1% of\npatients who received Inluriyo in combination with Verzenio included pneumonia\n(2.4%), abdominal pain, and renal failure (each 1.4%). Fatal adverse\nreactions occurred in 3.8% of patients who received Inluriyo in combination\nwith Verzenio, including pneumonia (1.4%), myocardial infarction, interstitial\nlung disease, and sepsis (0.5% each).\n\nMost Common Adverse Reactions for Inluriyo in combination with Verzenio: The\nmost common (≥10%) adverse reactions with Inluriyo in combination with\nVerzenio, including laboratory abnormalities, were decreased neutrophils,\ndiarrhea, decreased hemoglobin, decreased lymphocytes, nausea, decreased\nplatelets, fatigue, increased triglycerides, infections, increased AST,\nincreased creatinine, increased ALT, vomiting, musculoskeletal pain, abdominal\npain, decreased appetite, increased cholesterol, rash, cough, headache, and\ndecreased weight.\n\nStrong and moderate CYP3A inhibitors increased the exposure of abemaciclib\nplus its active metabolites to a clinically meaningful extent and may lead to\nincreased toxicity. Avoid concomitant use of ketoconazole. Ketoconazole is\npredicted to increase the AUC of abemaciclib by up to 16-fold. In patients\nwith recommended starting doses of 200 mg twice daily or 150 mg twice daily,\nreduce the Verzenio dose to 100 mg twice daily with concomitant use of strong\nCYP3A inhibitors other than ketoconazole. In patients who have had a dose\nreduction to 100 mg twice daily due to adverse reactions, further reduce the\nVerzenio dose to 50 mg twice daily with concomitant use of strong CYP3A\ninhibitors. If a patient taking Verzenio discontinues a strong CYP3A\ninhibitor, increase the Verzenio dose (after 3-5 half-lives of the inhibitor)\nto the dose that was used before starting the inhibitor. Patients should avoid\ngrapefruit products. With concomitant use of moderate CYP3A inhibitors,\nmonitor for adverse reactions and consider reducing the Verzenio dose in 50 mg\ndecrements.\n\nAvoid concomitant use of strong or moderate CYP3A inducers and consider\nalternative agents. Coadministration of strong or moderate CYP3A inducers\ndecreased the plasma concentrations of abemaciclib plus its active metabolites\nand may lead to reduced activity.\n\nWith severe hepatic impairment (Child-Pugh C), reduce the Verzenio dosing\nfrequency to once daily. No dosage adjustments are necessary in patients with\nmild or moderate hepatic impairment (Child-Pugh A or B).\n\nPlease see full Prescribing Information\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=1650388117&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4041638-1%26h%3D1452747158%26u%3Dhttps%253A%252F%252Fpi.lilly.com%252Fus%252Fverzenio-uspi.pdf%26a%3DPrescribing%2BInformation&a=Prescribing+Information)\nand Patient Information\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=462798302&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4041638-1%26h%3D1439763023%26u%3Dhttps%253A%252F%252Fpi.lilly.com%252Fus%252Fverzenio-us-ppi.pdf%26a%3DPatient%2BInformation&a=Patient+Information)\nfor Verzenio.\n\nVZ IN HCP ISI ALL APPR\n\nAbout Lilly\nLilly is a medicine company turning science into healing to make life better\nfor people around the world. We've been pioneering life-changing discoveries\nfor 150 years, and today our medicines help tens of millions of people across\nthe globe. Harnessing the power of biotechnology, chemistry and genetic\nmedicine, our scientists are urgently advancing new discoveries to solve some\nof the world's most significant health challenges: redefining diabetes care;\ntreating obesity and curtailing its most devastating long-term effects;\nadvancing the fight against Alzheimer's disease; providing solutions to some\nof the most debilitating immune system disorders; and transforming the most\ndifficult-to-treat cancers into manageable diseases. With each step toward a\nhealthier world, we're motivated by one thing: making life better for millions\nmore people. That includes delivering innovative clinical trials that reflect\nthe diversity of our world and working to ensure our medicines are accessible\nand affordable. To learn more, visit Lilly.com\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=973415295&u=https%3A%2F%2Fwww.lilly.com%2F%3Futm_source%3Dpr%26utm_medium%3Dreferral%26utm_campaign%3Dpr_boilerplate&a=Lilly.com)\n and Lilly.com/news\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=1160456343&u=https%3A%2F%2Fwww.lilly.com%2Fnews%3Futm_source%3Dpr%26utm_medium%3Dreferral%26utm_campaign%3Dpr_boilerplate&a=Lilly.com%2Fnews)\n, or follow us on Facebook\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=3433208564&u=https%3A%2F%2Fwww.facebook.com%2Felilillyandco%2F&a=Facebook)\n, Instagram\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=246100894&u=https%3A%2F%2Fwww.instagram.com%2Felilillyco%2F&a=Instagram)\n, and LinkedIn\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4799217-1&h=975317160&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Feli-lilly-and-company%2F&a=LinkedIn)\n. P-LLY\n\nTrademarks and Trade Names\nAll trademarks or trade names referred to in this press release are the\nproperty of the company, or, to the extent trademarks or trade names belonging\nto other companies are references in this press release, the property of their\nrespective owners. Solely for convenience, the trademarks and trade names in\nthis press release are referred to without the (®) and ™ symbols, but such\nreferences should not be construed as any indicator that the company or, to\nthe extent applicable, their respective owners will not assert, to the fullest\nextent under applicable law, the company's or their rights thereto. We do not\nintend the use or display of other companies' trademarks and trade names to\nimply a relationship with, or endorsement or sponsorship of us by, any other\ncompanies.\n\nCautionary Statement Regarding Forward-Looking Statements\nThis press release contains forward-looking statements (as that term is\ndefined in the Private Securities Litigation Reform Act of 1995) about\nsofetabart mipitecan as a potential treatment for ovarian cancer as well as\nother FRα-expressing solid tumors, olomorasib as a potential treatment for\ncertain KRAS G12C-mutant advanced solid tumors, Retevmo (selpercatinib) as a\ntreatment for advanced RET-mutant medullary thyroid cancer (MTC), and Verzenio\n(abemaciclib) as a treatment for certain HR+, HER2– breast cancers in the\nadjuvant and advanced or metastatic setting, and reflects Lilly's current\nbeliefs and expectations. However, as with any pharmaceutical product, there\nare substantial risks and uncertainties in the process of drug research,\ndevelopment, and commercialization. Among other things, there is no guarantee\nthat planned or ongoing studies will be completed as planned, that future\nstudy results will be consistent with study results to date, that any of these\ntherapies will prove to be a safe and effective treatment or receive\nregulatory approval, or that Lilly will execute its strategy as expected. For\nfurther discussion of these and other risks and uncertainties that could cause\nactual results to differ from Lilly's expectations, see Lilly's Form 10-K and\nForm 10-Q filings with the United States Securities and Exchange Commission.\nExcept as required by law, Lilly undertakes no duty to update forward-looking\nstatements to reflect events after the date of this release.\n\nEndnotes & References\n\n 1. Bax, Heather J et al. \"Folate receptor alpha in ovarian cancer tissue and\npatient serum is associated with disease burden and treatment outcomes.\"\nBritish journal of cancer vol. 128,2 (2023): 342-353.\ndoi:10.1038/s41416-022-02031-x\n 2. Scaranti, Mariana et al. \"Exploiting the folate receptor α in oncology.\"\nNature reviews. Clinical oncology vol. 17,6 (2020): 349-359.\ndoi:10.1038/s41571-020-0339-5.\n 3. Kalli, Kimberly R et al. \"Folate receptor alpha as a tumor target in\nepithelial ovarian cancer.\" Gynecologic oncology vol. 108,3 (2008): 619-26.\ndoi:10.1016/j.ygyno.2007.11.020.\n 4. Viricel W, et al. Cancer Res. 2023;83(suppl 7):1544.\n 5. Ji J, Wang C, Fakih M. Targeting KRAS G12C-mutated advanced colorectal cancer:\nResearch and clinical developments. OncoTargets and Therapy. 2022;Volume\n15:747-756. doi:10.2147/ott.s340392\n 6. Peng S-B, Si C, Zhang Y, et al. Abstract 1259: Preclinical characterization of\nLY3537982, a novel, highly selective and potent KRAS-G12C inhibitor. Cancer\nResearch. 2021;81(13_Supplement):1259-1259. doi:10.1158/1538-7445.am2021-1259\n 7. Retevmo. Prescribing information. Lilly USA, LLC.\n 8. Verzenio. Prescribing information. Lilly USA, LLC.\n 9. Inluriyo. Prescribing information. Lilly USA, LLC.\nRefer to:  Megan Talon; megan.talon@lilly.com (mailto:megan.talon@lilly.com)\n(Media)\n                 Michael Czapar; czapar_michael_c@lilly.com\n(mailto:czapar_michael_c@lilly.com) (Investors)\n\n \n\nView original content to download\nmultimedia:https://www.prnewswire.com/news-releases/lilly-to-showcase-advances-across-its-oncology-pipeline-at-the-2026-european-society-for-medical-oncology-esmo-congress-302911565.html\n(https://www.prnewswire.com/news-releases/lilly-to-showcase-advances-across-its-oncology-pipeline-at-the-2026-european-society-for-medical-oncology-esmo-congress-302911565.html)\n\nSOURCE Eli Lilly and Company\n\n\n\nPhoto: \nhttps://mmx.prnewswire.com/media/MS270365/ELI-LILLY-AND-COMPANY-LOGO.jpg?id=OA3022173\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-10-18T22:05:00.105132863Z","server_sent_at_ms":1792361100105},"received_at":"2026-10-18T22:05:00.611Z","source_url":"https://www.prnewswire.com/news-releases/lilly-to-showcase-advances-across-its-oncology-pipeline-at-the-2026-european-society-for-medical-oncology-esmo-congress-302911565.html"},"analysis":{"id":"160109","press_release_id":"171959","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Lilly announced its data lineup for the 2026 ESMO Congress (October 23-27, Madrid), with presentations across its oncology portfolio including rapid oral sessions for sofetabart mipitecan and olomorasib.\n\nFirst Phase 1 data for Sofe-M, Lilly's FRα-targeting ADC, in platinum-sensitive ovarian cancer supports the ongoing Phase 3 FRAmework-01 trial, and updated first-line data for olomorasib in KRAS G12C-mutant NSCLC support its Phase 3 SUNRAY-01 program.\n\nUpdated Phase 3 data for Retevmo in RET-mutant medullary thyroid cancer and overall survival data for Verzenio from the postMONARCH trial will also be presented. The release is a schedule announcement without topline results, so read-through is directional pipeline momentum rather than a material catalyst.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"ESMO data preview spotlights Lilly's next oncology growth drivers (Sofe-M ADC, olomorasib) ahead of Oct 23-27 presentations."},"keyFigures":{"customDimensions":{"kras_g12c_nsclc_prevalence":"13%","olomorasib_target_occupancy":">90%"}},"quotedText":"We're especially encouraged by the data we're sharing for sofetabart mipitecan in platinum-sensitive ovarian cancer, which build on what we've seen with this medicine in platinum-resistant disease and mark a critical step forward","namedEntities":{"people":[{"name":"Jacob Van Naarden","role":"EVP and President of Lilly Oncology"}],"products":["sofetabart mipitecan (Sofe-M)","olomorasib","Retevmo (selpercatinib)","Verzenio (abemaciclib)","bevacizumab","pembrolizumab","fulvestrant","Inluriyo (imlunestrant)"],"companies":[{"name":"Eli Lilly and Company","ticker":"LLY","relationship":"filer"},{"name":"European Society for Medical Oncology","relationship":"conference organizer"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"A conference data-presentation preview, not new topline results: no efficacy figures, endpoints, or regulatory decisions are disclosed. Positive signal for pipeline momentum (Sofe-M and olomorasib advancing in Phase 3) but routine for a mega-cap pharma."},"tickerRelevance":{"others":[],"primary":"LLY"},"globalImportance":25,"audienceRelevance":45,"eventTypeSecondary":["operations_update"],"importanceComponents":{"tickerTier":"mega-cap","eventGravity":"conference-preview-no-topline-data","sectorWeight":"pharma-pipeline-momentum","householdBrandBoost":true}},"event_type":"clinical_trial","event_type_secondary":["operations_update"],"sentiment":"bullish","material_impact_score":2,"narrative":"Lilly announced its data lineup for the 2026 ESMO Congress (October 23-27, Madrid), with presentations across its oncology portfolio including rapid oral sessions for sofetabart mipitecan and olomorasib.\n\nFirst Phase 1 data for Sofe-M, Lilly's FRα-targeting ADC, in platinum-sensitive ovarian cancer supports the ongoing Phase 3 FRAmework-01 trial, and updated first-line data for olomorasib in KRAS G12C-mutant NSCLC support its Phase 3 SUNRAY-01 program.\n\nUpdated Phase 3 data for Retevmo in RET-mutant medullary thyroid cancer and overall survival data for Verzenio from the postMONARCH trial will also be presented. The release is a schedule announcement without topline results, so read-through is directional pipeline momentum rather than a material catalyst.","key_figures":{"customDimensions":{"kras_g12c_nsclc_prevalence":"13%","olomorasib_target_occupancy":">90%"}},"named_entities":{"people":[{"name":"Jacob Van Naarden","role":"EVP and President of Lilly Oncology"}],"products":["sofetabart mipitecan (Sofe-M)","olomorasib","Retevmo (selpercatinib)","Verzenio (abemaciclib)","bevacizumab","pembrolizumab","fulvestrant","Inluriyo (imlunestrant)"],"companies":[{"name":"Eli Lilly and Company","ticker":"LLY","relationship":"filer"},{"name":"European Society for Medical Oncology","relationship":"conference organizer"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-18T22:05:05.768Z","global_importance":25,"audience_relevance":45,"importance_components":{"tickerTier":"mega-cap","eventGravity":"conference-preview-no-topline-data","sectorWeight":"pharma-pipeline-momentum","householdBrandBoost":true}},"durationMs":5110,"modelName":"glm-5.3-flashx"}}