{"success":true,"data":{"pressRelease":{"id":"149839","rtpr_id":"nBw33QTGRa-20260922","ticker":"4502","exchange":"TSE Tokyo","all_tickers":["4502"],"title":"Takeda Highlights Late-Stage Oncology Pipeline Progress and Solid Tumor Portfolio Research, Led by Late-Breaking Phase 3 Arcotatug Tavatecan (TAK-921) Data, at ESMO 2026","author":"Business Wire","published_at":"2026-09-22T13:30:00.307Z","article_body":"Takeda Highlights Late-Stage Oncology Pipeline Progress and Solid Tumor\nPortfolio Research, Led by Late-Breaking Phase 3 Arcotatug Tavatecan (TAK-921)\nData, at ESMO 2026\n\n\n * Late-Breaking Abstract to Feature New Data from First Phase 3 Registrational\nStudy of Arcotatug Tavatecan in Previously Treated Advanced Gastric Cancer\n\n * TAK-928 Presentations Reinforce Potential in Patients with\nImmunotherapy-Resistant Non-Small Cell Lung Cancer (NSCLC) and Previously\nUntreated NSCLC\n\n * Takeda Continues to Progress Clinical Development of Arcotatug Tavatecan and\nTAK-928; New Non-Squamous NSCLC Sub-Trial Added to Global Phase 3 MarsLight-11\nStudy Evaluating TAK-928 vs. Docetaxel Monotherapy\n\nTakeda (TSE:4502/NYSE:TAK\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=7cd99f6cd52cb0e172c45451efbfa0c9)\n) announced that new data from its oncology pipeline and portfolio will be\npresented at the European Society for Medical Oncology (ESMO)\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.esmo.org%2Fmeeting-calendar%2Fesmo-congress-2026&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=European+Society+for+Medical+Oncology+%28ESMO%29&index=2&md5=f16a9170dab6f492a4acfe3bd40a19d4)\nCongress, taking place October 23-27, 2026, in Madrid, Spain. Key data will\ninclude a late-breaking abstract on arcotatug tavatecan (TAK-921; Innovent\nR&D code: IBI343*) and two presentations on TAK-928 (Innovent R&D\ncode: IBI363*). Clinical and real-world analyses of ALUNBRIG(®) (brigatinib)\nand FRUZAQLA(®) (fruquintinib) will also be shared at the congress.\n\n“Takeda’s data at ESMO reflect our commitment to delivering rapid progress\nfor patients living with some of the most prevalent and challenging cancers,\nincluding advanced gastric cancer and immunotherapy-resistant and previously\nuntreated non-small cell lung cancer,” said Phuong Khanh (P.K.) Morrow,\nM.D., Head of the Oncology Therapeutic Area Unit at Takeda. “Our mission is\nto advance new therapeutic approaches for patients who need more options or\nwho remain underserved by current standards of care. Together, our late-stage\noncology pipeline and portfolio of thoracic and gastrointestinal cancer\nmedicines are helping address patients’ needs today while building\npossibilities for the future.”\n\nLate-breaking data from the Phase 3 G-HOPE-001 study (NCT06238843) of\narcotatug tavatecan being conducted in Japan and China in patients with\npreviously treated advanced gastric or gastroesophageal junction\nadenocarcinoma (G/GEJA) will be presented during the ESMO proffered paper\nsession on October 23, 13:30-15:00 CEST (Abstract LBA77). Arcotatug tavatecan\nis an investigational Claudin 18.2-targeted antibody-drug conjugate (ADC) with\nan exatecan payload and an Fc-silenced backbone designed to reduce Fc-mediated\ntoxicities. Pending evaluation of final study results, data from G-HOPE-001\ncould support a potential regulatory filing for this indication in Japan.\n\nAdditionally, new findings for TAK-928 plus bevacizumab in\nimmunotherapy-resistant non-small cell lung cancer (NSCLC) and TAK-928 plus\nchemotherapy in first-line NSCLC will be featured in two presentations.\nTAK-928 is a potential first-in-class PD-1/alpha-biased IL-2 bispecific fusion\nprotein. Based on data showing promising efficacy and manageable safety in\nNSCLC to date, Takeda is conducting the global Phase 3 MarsLight-11 study\n(NCT07217301) evaluating TAK-928 vs. docetaxel in patients with squamous NSCLC\nwhose disease has progressed on or after chemotherapy and immunotherapy.\nEnrollment is ongoing at trial sites globally, including in the U.S. In\naddition, Takeda will expand the MarsLight-11 study to include a new sub-trial\nfor patients with non-squamous NSCLC.\n\nTakeda is committed to developing oncology medicines in three strategic areas\nof focus: hematologic, thoracic and gastrointestinal cancers. Further\npresentations at ESMO 2026 will highlight clinical and real-world analyses\nspanning Takeda’s approved medicines across thoracic and gastrointestinal\ncancers, including:\n\n\n * Real-world interim results on treatment patterns and outcomes with ALUNBRIG as\na first-line treatment for adults with anaplastic lymphoma kinase positive\n(ALK+) NSCLC to be presented as an e-poster\n\n * Updated results from a global FRUZAQLA Expanded Access Program for patients\nwith previously treated metastatic colorectal cancer (mCRC) to be presented as\na poster\n\nArcotatug tavatecan and TAK-928 are investigational compounds that have not\nbeen approved for use by the U.S. FDA or any other regulatory authorities.\n\n*Innovent refers to arcotatug tavatecan (TAK-921) and TAK-928 as IBI343 and\nIBI363, respectively. Takeda entered into a license and collaboration\nagreement with Innovent. Under the agreement, Takeda holds the rights to\ndevelop, manufacture and commercialize arcotatug tavatecan worldwide outside\nof greater China. For TAK-928, Takeda will lead global co-development and U.S.\nco-commercialization and has exclusive commercialization rights outside the\nU.S. and Greater China.\n\nALUNBRIG(®) (brigatinib) IMPORTANT SAFETY INFORMATION\n\nINDICATION\n\nALUNBRIG is a kinase inhibitor indicated for the treatment of adult patients\nwith anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung\ncancer (NSCLC) as detected by an FDA-approved test.\n\nWARNINGS AND PRECAUTIONS\n\nInterstitial Lung Disease (ILD)/Pneumonitis\n\nSevere, life-threatening, and fatal pulmonary adverse reactions consistent\nwith interstitial lung disease (ILD)/pneumonitis have occurred with ALUNBRIG.\nIn ALTA 1L, ILD/pneumonitis occurred in 5.1% of patients receiving ALUNBRIG.\nILD/pneumonitis occurred within 8 days of initiation of ALUNBRIG in 2.9% of\npatients, with Grade 3 to 4 reactions occurring in 2.2% of patients. In the\nALTA study, at the approved dose (90→180 mg), ILD/pneumonitis occurred in\n9.1% of patients. Monitor for new or worsening respiratory symptoms (dyspnea,\ncough, etc.), particularly during the first week of initiating ALUNBRIG.\nWithhold ALUNBRIG in any patient with new or worsening respiratory symptoms,\nand promptly evaluate for ILD/pneumonitis or other causes of respiratory\nsymptoms (e.g., pulmonary embolism, tumor progression, and infectious\npneumonia). For Grade 1 or 2 ILD/pneumonitis, either dose reduce or\npermanently discontinue ALUNBRIG. Permanently discontinue ALUNBRIG for Grade 3\nor 4 ILD/pneumonitis or recurrence of Grade 1 or 2 ILD/pneumonitis.\n\nHypertension\n\nIn ALTA 1L, hypertension was reported in 32% of patients receiving ALUNBRIG;\n13% of patients experienced Grade 3 hypertension. Control blood pressure prior\nto treatment with ALUNBRIG. Monitor blood pressure and withhold ALUNBRIG for\nGrade 3 hypertension despite optimal antihypertensive therapy. Consider\npermanent discontinuation of treatment with ALUNBRIG for Grade 4 hypertension\nor recurrence of Grade 3 hypertension. Use caution when administering ALUNBRIG\nin combination with antihypertensive agents that cause bradycardia.\n\nBradycardia\n\nIn ALTA 1L, heart rates less than 50 beats per minute (bpm) occurred in 8.1%\nof patients receiving ALUNBRIG; one patient (0.7%) experienced Grade 3\nbradycardia. Monitor heart rate and blood pressure during treatment with\nALUNBRIG. For symptomatic bradycardia, withhold ALUNBRIG and review\nconcomitant medications for those known to cause bradycardia; dose reduce\nconcomitant medication or ALUNBRIG as appropriate. Discontinue ALUNBRIG for\nlife-threatening bradycardia if no contributing concomitant medication is\nidentified.\n\nVisual Disturbance\n\nIn ALTA 1L, Grade 1 or 2 adverse reactions leading to visual disturbance,\nincluding blurred vision, photophobia, photopsia, and reduced visual acuity,\nwere reported in 7.4% of patients receiving ALUNBRIG. In the ALTA study, at\nthe approved dose (90→180 mg), Grade 3 macular edema and cataract occurred\nin one patient each. Advise patients to report any visual symptoms. Withhold\nALUNBRIG and obtain an ophthalmologic evaluation in patients with new or\nworsening visual symptoms of Grade 2 or greater severity; upon recovery, dose\nreduce as appropriate. Permanently discontinue treatment with ALUNBRIG for\nGrade 4 visual disturbances.\n\nCreatine Phosphokinase (CPK) Elevation\n\nIn ALTA 1L, creatine phosphokinase (CPK) elevation occurred in 81% of patients\nwho received ALUNBRIG. The incidence of Grade 3 or 4 CPK elevation was 24%.\nDose reduction for CPK elevation occurred in 15% of patients. Advise patients\nto report any unexplained muscle pain, tenderness, or weakness. Monitor CPK\nlevels during ALUNBRIG treatment. Withhold ALUNBRIG for Grade 3 or 4 CPK\nelevation with Grade 2 or higher muscle pain or weakness. Upon resolution or\nrecovery to Grade 1 CPK elevation or baseline, resume ALUNBRIG at the same\ndose or at a reduced dose.\n\nPancreatic Enzyme Elevation\n\nIn ALTA 1L, amylase elevation occurred in 52% of patients and Grade 3 or 4\namylase elevation occurred in 6.8% of patients who received ALUNBRIG. Lipase\nelevations occurred in 59% of patients and Grade 3 or 4 lipase elevation\noccurred in 17% of patients. Monitor lipase and amylase during treatment with\nALUNBRIG. Withhold ALUNBRIG for Grade 3 or 4 pancreatic enzyme elevation. Upon\nresolution or recovery to Grade 1 or baseline, resume ALUNBRIG at the same\ndose or at a reduced dose.\n\nHepatotoxicity\n\nIn ALTA 1L, aspartate aminotransferase (AST) elevations occurred in 72% of\npatients and Grade 3 or 4 AST elevations occurred in 4.5% of patients who\nreceived ALUNBRIG. Alanine aminotransferase (ALT) elevations occurred in 52%\nof patients and Grade 3 or 4 ALT elevations occurred in 5.2% of patients. One\npatient (0.7%) had a serious adverse reaction of hepatocellular injury.\nMonitor AST, ALT and total bilirubin during treatment with ALUNBRIG,\nespecially during the first 3 months. Withhold ALUNBRIG for Grade 3 or 4\nhepatic enzyme elevation with bilirubin less than or equal to 2 × ULN. Upon\nresolution or recovery to Grade 1 or less (less than or equal to 3 × ULN) or\nto baseline, resume ALUNBRIG at a next lower dose. Permanently discontinue\nALUNBRIG for Grade 2 to 4 hepatic enzyme elevation with concurrent total\nbilirubin elevation greater than 2 times the ULN in the absence of cholestasis\nor hemolysis.\n\nHyperglycemia\n\nIn ALTA 1L, 56% of patients who received ALUNBRIG experienced new or worsening\nhyperglycemia. Grade 3 hyperglycemia, based on laboratory assessment of serum\nfasting glucose levels, occurred in 7.5% of patients. In the ALTA study, 2 of\n20 (10%) patients with diabetes or glucose intolerance at baseline required\ninitiation of insulin while receiving ALUNBRIG. Assess fasting serum glucose\nprior to initiation of ALUNBRIG and monitor periodically thereafter. Initiate\nor optimize anti-hyperglycemic medications as needed. If adequate\nhyperglycemic control cannot be achieved with optimal medical management,\nwithhold ALUNBRIG until adequate hyperglycemic control is achieved and\nconsider reducing the dose of ALUNBRIG.\n\nPhotosensitivity\n\nIn ALTA 1L, 3.7% of patients who received ALUNBRIG experienced\nphotosensitivity, with 0.7% of patients experiencing Grade 3 to 4 reactions.\nAdvise patients to limit sun exposure while taking ALUNBRIG, and for at least\n5 days after discontinuation of treatment. Advise patients, when outdoors, to\nwear protective clothing and use a broad-spectrum sunscreen (SPF ≥30) to\nhelp protect against sunburn. Based on the severity, withhold ALUNBRIG, then\nresume at the same dose, or reduce the dose, or permanently discontinue.\n\nEmbryo-Fetal Toxicity\n\nBased on its mechanism of action and findings in animals, ALUNBRIG can cause\nfetal harm when administered to pregnant women. There are no clinical data on\nthe use of ALUNBRIG in pregnant women. Advise women of the potential risk to a\nfetus.\n\nADVERSE REACTIONS\n\nThe most common adverse reactions (≥25%) with ALUNBRIG were diarrhea,\nfatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, and\ndyspnea.\n\nDRUG INTERACTIONS\n\nCYP3A Inhibitors: Avoid coadministration of ALUNBRIG with strong or moderate\nCYP3A inhibitors. If coadministration of a strong or moderate CYP3A inhibitor\nis unavoidable, reduce the dose of ALUNBRIG.\n\nCYP3A Inducers: Avoid coadministration of ALUNBRIG with strong or moderate\nCYP3A inducers. If coadministration of a moderate CYP3A inducer is\nunavoidable, increase the dose of ALUNBRIG.\n\nUSE IN SPECIFIC POPULATIONS\n\nFemales and Males of Reproductive Potential\n\nVerify pregnancy status in females of reproductive potential prior to\ninitiating ALUNBRIG. Advise females of reproductive potential to use effective\ncontraception during treatment with ALUNBRIG and for at least 4 months after\nthe final dose. Advise males with female partners of reproductive potential to\nuse effective contraception during treatment with ALUNBRIG and for at least 3\nmonths after the final dose. ALUNBRIG may cause reduced fertility in males.\n\nLactation: Advise patients not to breastfeed.\n\nHepatic Impairment: Reduce the dose of ALUNBRIG for patients with severe\nhepatic impairment.\n\nRenal Impairment: Reduce the dose of ALUNBRIG for patients with severe renal\nimpairment.\n\nTo report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A.,\nInc. at 1-844-217-6468 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.fda.gov%2Fsafety%2Fmedwatch-fda-safety-information-and-adverse-event-reporting-program&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=www.fda.gov%2Fmedwatch&index=3&md5=18979815deaf68e593a8a3799df1d1d5)\n.\n\nPlease see full Prescribing Information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.alunbrig.com%2Fsites%2Fdefault%2Ffiles%2F2022-10%2Fprescribing-information.pdf&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=Prescribing+Information&index=4&md5=d5847bdb9f64412da55c052fb69b0e12)\n.\n\nFRUZAQLA(®) (fruquintinib) IMPORTANT SAFETY INFORMATION\n\nINDICATION\n\nFRUZAQLA is indicated for the treatment of adult patients with metastatic\ncolorectal cancer (mCRC) who have been previously treated with\nfluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an\nanti-VEGF therapy, and, if RAS wild-type and medically appropriate, an\nanti-EGFR therapy.\n\nWARNINGS AND PRECAUTIONS\n\n\n * Hypertension occurred in 49% of 911 patients with mCRC treated with FRUZAQLA,\nincluding Grade 3-4 events in 19%, and hypertensive crisis in three patients\n(0.3%). Do not initiate FRUZAQLA unless blood pressure is adequately\ncontrolled. Monitor blood pressure weekly for the first month and at least\nmonthly thereafter as clinically indicated. Initiate or adjust\nanti-hypertensive therapy as appropriate. Withhold, reduce dose, or\npermanently discontinue FRUZAQLA based on severity of hypertension.\n\n\n * Hemorrhagic Events including serious, fatal events can occur with FRUZAQLA. In\n911 patients with mCRC treated with FRUZAQLA, 6% of patients experienced\ngastrointestinal hemorrhage, including 1% with a Grade ≥3 event and 2\npatients with fatal hemorrhages. Permanently discontinue FRUZAQLA in patients\nwith severe or life-threatening hemorrhage. Monitor the International\nNormalized Ratio (INR) levels in patients receiving anticoagulants.\n\n\n * Infections. FRUZAQLA can increase the risk of infections, including fatal\ninfections. In 911 patients with mCRC treated with FRUZAQLA, the most common\ninfections were urinary tract infections (6.8%), upper respiratory tract\ninfections (3.2%) and pneumonia (2.5%); fatal infections included pneumonia\n(0.4%), sepsis (0.2%), bacterial infection (0.1%), lower respiratory tract\ninfection (0.1%), and septic shock (0.1%). Withhold FRUZAQLA for Grade 3 or 4\ninfections, or worsening infection of any grade. Resume FRUZAQLA at the same\ndose when the infection has resolved.\n\n\n * Gastrointestinal Perforation occurred in patients treated with FRUZAQLA. In\n911 patients with mCRC treated with FRUZAQLA, 1.3% experienced a Grade ≥3\ngastrointestinal perforation, including one fatal event. Permanently\ndiscontinue FRUZAQLA in patients who develop gastrointestinal perforation or\nfistula.\n\n\n * Hepatotoxicity. FRUZAQLA can cause liver injury. In 911 patients with mCRC\ntreated with FRUZAQLA, 48% experienced increased ALT or AST, including Grade\n≥3 events in 5%, and fatal events in 0.2% of patients. Monitor liver\nfunction tests (ALT, AST, and bilirubin) before initiation and periodically\nthroughout treatment with FRUZAQLA. Temporarily hold and then reduce or\npermanently discontinue FRUZAQLA depending on the severity and persistence of\nhepatotoxicity as manifested by elevated liver function tests.\n\n\n * Proteinuria. FRUZAQLA can cause proteinuria. In 911 patients with mCRC treated\nwith FRUZAQLA, 36% experienced proteinuria and 2.5% of patients experienced\nGrade ≥3 events. Monitor for proteinuria before initiation and periodically\nthroughout treatment with FRUZAQLA. For proteinuria ≥2g/24 hours, withhold\nFRUZAQLA until improvement to ≤Grade 1 proteinuria and resume FRUZAQLA at a\nreduced dose. Discontinue FRUZAQLA in patients who develop nephrotic syndrome.\n\n\n * Palmar-Plantar Erythrodysesthesia (PPE) occurred in 35% of 911 patients\ntreated with FRUZAQLA, including 8% with Grade 3 events. Based on severity of\nPPE, withhold FRUZAQLA and then resume at the same or reduced dose.\n\n\n * Posterior Reversible Encephalopathy Syndrome (PRES), a syndrome of subcortical\nvasogenic edema diagnosed by characteristic finding on MRI, occurred in one of\n911 patients treated with FRUZAQLA. Perform an evaluation for PRES in any\npatient presenting with seizures, headache, visual disturbances, confusion, or\naltered mental function. Discontinue FRUZAQLA in patients who develop PRES.\n\n\n * Impaired Wound Healing. In 911 patients with mCRC treated with FRUZAQLA, 1\npatient experienced a Grade 2 event of wound dehiscence. Do not administer\nFRUZAQLA for at least 2 weeks prior to major surgery. Do not administer\nFRUZAQLA for at least 2 weeks after major surgery and until adequate wound\nhealing. The safety of resumption of FRUZAQLA after resolution of wound\nhealing complications has not been established.\n\n\n * Arterial Thromboembolic Events. In 911 patients with mCRC treated with\nFRUZAQLA, 0.8% of patients experienced an arterial thromboembolic event.\nInitiation of FRUZAQLA in patients with a recent history of thromboembolic\nevents should be carefully considered. In patients who develop arterial\nthromboembolism, discontinue FRUZAQLA.\n\n\n * Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) and No. 6 (Sunset\nYellow FCF). FRUZAQLA 1 mg capsules contain FD&C Yellow No. 5\n(tartrazine), which may cause allergic-type reactions (including bronchial\nasthma) in certain susceptible persons. FRUZAQLA 1 mg contains FD&C Yellow\nNo. 6 (sunset yellow FCF), which may cause allergic reactions.\n\n\n * Embryo-Fetal Toxicity. Based on findings in animal studies and its mechanism\nof action, FRUZAQLA can cause fetal harm when administered to pregnant women.\nAdvise pregnant women of the potential risk to a fetus.\n\nADVERSE REACTIONS\n\nThe most common adverse reactions (incidence ≥20%) following treatment with\nFRUZAQLA included hypertension, palmar-plantar erythrodysesthesia (hand-foot\nskin reactions), proteinuria, dysphonia, abdominal pain, diarrhea, and\nasthenia.\n\nDRUG INTERACTIONS\n\nAvoid concomitant administration of FRUZAQLA with strong or moderate CYP3A\ninducers.\n\nUSE IN SPECIFIC POPULATIONS\n\n\n * Lactation: Advise women not to breastfeed during treatment with FRUZAQLA and\nfor 2 weeks after the last dose.\n\n\n * Females and Males of Reproductive Potential\n\n\n * Pregnancy Testing: Verify pregnancy status of females of reproductive\npotential prior to initiating FRUZAQLA.\n\n\n * Contraception: Females of childbearing potential and males with female\npartners of childbearing potential should use effective contraception during\ntreatment and for 2 weeks after the last dose of FRUZAQLA.\n\n\n * Infertility: Advise females of reproductive potential that FRUZAQLA may cause\npost-implantation loss.\n\nTo report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at\n1-844-662-8532 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.fda.gov%2Fsafety%2Fmedwatch-fda-safety-information-and-adverse-event-reporting-program&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=www.fda.gov%2Fmedwatch&index=5&md5=fd8a8a9cf080645440ab7665eb52b8b6)\n.\n\nPlease see FRUZAQLA (fruquintinib) full Prescribing Information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftakeda.info%2FFruzaqla-Prescribing-Information&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=Prescribing+Information&index=6&md5=416a3254606853bdff03d4a134d8eba0)\n.\n\nTakeda’s Commitment to Oncology\n\nAt Takeda Oncology, we are united by our aspiration to cure cancer, with\ninspiration from patients and innovation from everywhere. Drawing on decades\nof leadership in oncology, we work to develop innovative treatments that\nenhance and extend the lives of people living with cancer. We are committed to\nensuring that patients globally can benefit from and access our portfolio of\nmedicines, while also progressing a pipeline of potential treatments for the\nfuture. Our research and development efforts are focused on advancing\nmedicines for hematologic, gastrointestinal and thoracic cancers by leveraging\nmodalities best suited to make a difference in the treatment of these\ndiseases. We complement our internal expertise and global footprint with a\nrobust network of collaborators. Together, we strive to bring life-changing\nmedicines to more patients around the world. For more information, visit\nwww.takedaoncology.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takedaoncology.com%2F&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=www.takedaoncology.com&index=7&md5=2ab871580db53a461a5dabcd1dd2a83b)\n.\n\nAbout Takeda\n\nTakeda is focused on creating better health for people and a brighter future\nfor the world. We aim to discover and deliver life-transforming treatments in\nour core therapeutic and business areas, including gastrointestinal and\ninflammation, rare diseases, plasma-derived therapies, oncology, neuroscience\nand vaccines. Together with our partners, we aim to improve the patient\nexperience and advance a new frontier of treatment options through our dynamic\nand diverse pipeline. As a leading values-based, R&D-driven\nbiopharmaceutical company headquartered in Japan, we are guided by our\ncommitment to patients, our people and the planet. Our employees in\napproximately 80 countries and regions are driven by our purpose and are\ngrounded in the values that have defined us for more than two centuries. For\nmore information, visit www.takeda.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.takeda.com&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=www.takeda.com&index=8&md5=c938357c03afbb559bbb46d97dd9ff9c)\n.\n\nImportant Notice\n\nFor the purposes of this notice, “press release” means this document, any\noral presentation, any question and answer session and any written or oral\nmaterial discussed or distributed by Takeda Pharmaceutical Company Limited\n(“Takeda”) regarding this release. This press release (including any oral\nbriefing and any question-and-answer in connection with it) is not intended\nto, and does not constitute, represent or form part of any offer, invitation\nor solicitation of any offer to purchase, otherwise acquire, subscribe for,\nexchange, sell or otherwise dispose of, any securities or the solicitation of\nany vote or approval in any jurisdiction. No shares or other securities are\nbeing offered to the public by means of this press release. No offering of\nsecurities shall be made in the United States except pursuant to registration\nunder the U.S. Securities Act of 1933, as amended, or an exemption therefrom.\nThis press release is being given (together with any further information which\nmay be provided to the recipient) on the condition that it is for use by the\nrecipient for information purposes only (and not for the evaluation of any\ninvestment, acquisition, disposal or any other transaction). Any failure to\ncomply with these restrictions may constitute a violation of applicable\nsecurities laws. The companies in which Takeda directly and indirectly owns\ninvestments are separate entities. In this press release, “Takeda” is\nsometimes used for convenience where references are made to Takeda and its\nsubsidiaries in general. Likewise, the words “we”, “us” and “our”\nare also used to refer to subsidiaries in general or to those who work for\nthem. These expressions are also used where no useful purpose is served by\nidentifying the particular company or companies.\n\nForward-Looking Statements\n\nThis press release and any materials distributed in connection with this press\nrelease may contain forward-looking statements, beliefs or opinions regarding\nTakeda’s future business, future position and results of operations,\nincluding estimates, forecasts, targets and plans for Takeda. Without\nlimitation, forward-looking statements often include words such as\n“targets”, “plans”, “believes”, “hopes”, “continues”,\n“expects”, “aims”, “intends”, “ensures”, “will”,\n“may”, “should”, “would”, “could”, “anticipates”,\n“estimates”, “projects”, “forecasts”, “outlook” or similar\nexpressions or the negative thereof. These forward-looking statements are\nbased on assumptions about many important factors, including the following,\nwhich could cause actual results to differ materially from those expressed or\nimplied by the forward-looking statements: the economic circumstances\nsurrounding Takeda’s global business, including general economic conditions\nin Japan and the United States and with respect to international trade\nrelations; competitive pressures and developments; changes to applicable laws\nand regulations, including drug pricing, tax, tariff and other trade-related\nrules; challenges inherent in new product development, including uncertainty\nof clinical success and decisions of regulatory authorities and the timing\nthereof; uncertainty of commercial success for new and existing products;\nmanufacturing difficulties or delays; fluctuations in interest and currency\nexchange rates; claims or concerns regarding the safety or efficacy of\nmarketed products or product candidates; the impact of health crises, like the\nnovel coronavirus pandemic; the success of our environmental sustainability\nefforts, in enabling us to reduce our greenhouse gas emissions or meet our\nother environmental goals; the extent to which our efforts to increase\nefficiency, productivity or cost-savings, such as the integration of digital\ntechnologies, including artificial intelligence, in our business or other\ninitiatives to restructure our operations will lead to the expected benefits;\nand other factors identified in Takeda’s most recent Annual Report on Form\n20-F and Takeda’s other reports filed with the U.S. Securities and Exchange\nCommission, available on Takeda’s website at:\nhttps://www.takeda.com/investors/sec-filings-and-security-reports/\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Fsec-filings-and-security-reports%2F&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Fsec-filings-and-security-reports%2F&index=9&md5=4748a5a71a852a58077c56535e75e3af)\nor at www.sec.gov\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=www.sec.gov&index=10&md5=6c5b8c0ca77b419d3e9d69cb44d35826)\n. Takeda does not undertake to update any of the forward-looking statements\ncontained in this press release or any other forward-looking statements it may\nmake, except as required by law or stock exchange rule. Past performance is\nnot an indicator of future results and the results or statements of Takeda in\nthis press release may not be indicative of, and are not an estimate,\nforecast, guarantee or projection of Takeda’s future results.\n\nMedical Information\n\nThis press release contains information about products that may not be\navailable in all countries, or may be available under different trademarks,\nfor different indications, in different dosages, or in different strengths.\nNothing contained herein should be considered a solicitation, promotion or\nadvertisement for any prescription drugs including the ones under development.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260921356638/en/\n(https://www.businesswire.com/news/home/20260921356638/en/)\n\nMedia Relations:\n\n\n\nInvestor Relations \n\nChristopher O’Reilly\n\ntakeda.ir.contact@takeda.com \n(mailto:takeda.ir.contact@takeda.com) \n\n\nJapanese Media \n\nTsuyoshi Tada\n\ntoiawase_kouhou@takeda.co.jp \n(mailto:toiawase_kouhou@takeda.co.jp) \n\n\nU.S. and International Media \n\nHollie Wyatt\n\nhollie.wyatt@takeda.com (mailto:hollie.wyatt@takeda.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw33QTGRa-20260922","title":"Takeda Highlights Late-Stage Oncology Pipeline Progress and Solid Tumor Portfolio Research, Led by Late-Breaking Phase 3 Arcotatug Tavatecan (TAK-921) Data, at ESMO 2026","author":"Business Wire","ticker":"4502","created":"2026-09-22T13:30:00.307Z","tickers":["4502"],"exchange":"TSE Tokyo","article_body":"Takeda Highlights Late-Stage Oncology Pipeline Progress and Solid Tumor\nPortfolio Research, Led by Late-Breaking Phase 3 Arcotatug Tavatecan (TAK-921)\nData, at ESMO 2026\n\n\n * Late-Breaking Abstract to Feature New Data from First Phase 3 Registrational\nStudy of Arcotatug Tavatecan in Previously Treated Advanced Gastric Cancer\n\n * TAK-928 Presentations Reinforce Potential in Patients with\nImmunotherapy-Resistant Non-Small Cell Lung Cancer (NSCLC) and Previously\nUntreated NSCLC\n\n * Takeda Continues to Progress Clinical Development of Arcotatug Tavatecan and\nTAK-928; New Non-Squamous NSCLC Sub-Trial Added to Global Phase 3 MarsLight-11\nStudy Evaluating TAK-928 vs. Docetaxel Monotherapy\n\nTakeda (TSE:4502/NYSE:TAK\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=7cd99f6cd52cb0e172c45451efbfa0c9)\n) announced that new data from its oncology pipeline and portfolio will be\npresented at the European Society for Medical Oncology (ESMO)\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.esmo.org%2Fmeeting-calendar%2Fesmo-congress-2026&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=European+Society+for+Medical+Oncology+%28ESMO%29&index=2&md5=f16a9170dab6f492a4acfe3bd40a19d4)\nCongress, taking place October 23-27, 2026, in Madrid, Spain. Key data will\ninclude a late-breaking abstract on arcotatug tavatecan (TAK-921; Innovent\nR&D code: IBI343*) and two presentations on TAK-928 (Innovent R&D\ncode: IBI363*). Clinical and real-world analyses of ALUNBRIG(®) (brigatinib)\nand FRUZAQLA(®) (fruquintinib) will also be shared at the congress.\n\n“Takeda’s data at ESMO reflect our commitment to delivering rapid progress\nfor patients living with some of the most prevalent and challenging cancers,\nincluding advanced gastric cancer and immunotherapy-resistant and previously\nuntreated non-small cell lung cancer,” said Phuong Khanh (P.K.) Morrow,\nM.D., Head of the Oncology Therapeutic Area Unit at Takeda. “Our mission is\nto advance new therapeutic approaches for patients who need more options or\nwho remain underserved by current standards of care. Together, our late-stage\noncology pipeline and portfolio of thoracic and gastrointestinal cancer\nmedicines are helping address patients’ needs today while building\npossibilities for the future.”\n\nLate-breaking data from the Phase 3 G-HOPE-001 study (NCT06238843) of\narcotatug tavatecan being conducted in Japan and China in patients with\npreviously treated advanced gastric or gastroesophageal junction\nadenocarcinoma (G/GEJA) will be presented during the ESMO proffered paper\nsession on October 23, 13:30-15:00 CEST (Abstract LBA77). Arcotatug tavatecan\nis an investigational Claudin 18.2-targeted antibody-drug conjugate (ADC) with\nan exatecan payload and an Fc-silenced backbone designed to reduce Fc-mediated\ntoxicities. Pending evaluation of final study results, data from G-HOPE-001\ncould support a potential regulatory filing for this indication in Japan.\n\nAdditionally, new findings for TAK-928 plus bevacizumab in\nimmunotherapy-resistant non-small cell lung cancer (NSCLC) and TAK-928 plus\nchemotherapy in first-line NSCLC will be featured in two presentations.\nTAK-928 is a potential first-in-class PD-1/alpha-biased IL-2 bispecific fusion\nprotein. Based on data showing promising efficacy and manageable safety in\nNSCLC to date, Takeda is conducting the global Phase 3 MarsLight-11 study\n(NCT07217301) evaluating TAK-928 vs. docetaxel in patients with squamous NSCLC\nwhose disease has progressed on or after chemotherapy and immunotherapy.\nEnrollment is ongoing at trial sites globally, including in the U.S. In\naddition, Takeda will expand the MarsLight-11 study to include a new sub-trial\nfor patients with non-squamous NSCLC.\n\nTakeda is committed to developing oncology medicines in three strategic areas\nof focus: hematologic, thoracic and gastrointestinal cancers. Further\npresentations at ESMO 2026 will highlight clinical and real-world analyses\nspanning Takeda’s approved medicines across thoracic and gastrointestinal\ncancers, including:\n\n\n * Real-world interim results on treatment patterns and outcomes with ALUNBRIG as\na first-line treatment for adults with anaplastic lymphoma kinase positive\n(ALK+) NSCLC to be presented as an e-poster\n\n * Updated results from a global FRUZAQLA Expanded Access Program for patients\nwith previously treated metastatic colorectal cancer (mCRC) to be presented as\na poster\n\nArcotatug tavatecan and TAK-928 are investigational compounds that have not\nbeen approved for use by the U.S. FDA or any other regulatory authorities.\n\n*Innovent refers to arcotatug tavatecan (TAK-921) and TAK-928 as IBI343 and\nIBI363, respectively. Takeda entered into a license and collaboration\nagreement with Innovent. Under the agreement, Takeda holds the rights to\ndevelop, manufacture and commercialize arcotatug tavatecan worldwide outside\nof greater China. For TAK-928, Takeda will lead global co-development and U.S.\nco-commercialization and has exclusive commercialization rights outside the\nU.S. and Greater China.\n\nALUNBRIG(®) (brigatinib) IMPORTANT SAFETY INFORMATION\n\nINDICATION\n\nALUNBRIG is a kinase inhibitor indicated for the treatment of adult patients\nwith anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung\ncancer (NSCLC) as detected by an FDA-approved test.\n\nWARNINGS AND PRECAUTIONS\n\nInterstitial Lung Disease (ILD)/Pneumonitis\n\nSevere, life-threatening, and fatal pulmonary adverse reactions consistent\nwith interstitial lung disease (ILD)/pneumonitis have occurred with ALUNBRIG.\nIn ALTA 1L, ILD/pneumonitis occurred in 5.1% of patients receiving ALUNBRIG.\nILD/pneumonitis occurred within 8 days of initiation of ALUNBRIG in 2.9% of\npatients, with Grade 3 to 4 reactions occurring in 2.2% of patients. In the\nALTA study, at the approved dose (90→180 mg), ILD/pneumonitis occurred in\n9.1% of patients. Monitor for new or worsening respiratory symptoms (dyspnea,\ncough, etc.), particularly during the first week of initiating ALUNBRIG.\nWithhold ALUNBRIG in any patient with new or worsening respiratory symptoms,\nand promptly evaluate for ILD/pneumonitis or other causes of respiratory\nsymptoms (e.g., pulmonary embolism, tumor progression, and infectious\npneumonia). For Grade 1 or 2 ILD/pneumonitis, either dose reduce or\npermanently discontinue ALUNBRIG. Permanently discontinue ALUNBRIG for Grade 3\nor 4 ILD/pneumonitis or recurrence of Grade 1 or 2 ILD/pneumonitis.\n\nHypertension\n\nIn ALTA 1L, hypertension was reported in 32% of patients receiving ALUNBRIG;\n13% of patients experienced Grade 3 hypertension. Control blood pressure prior\nto treatment with ALUNBRIG. Monitor blood pressure and withhold ALUNBRIG for\nGrade 3 hypertension despite optimal antihypertensive therapy. Consider\npermanent discontinuation of treatment with ALUNBRIG for Grade 4 hypertension\nor recurrence of Grade 3 hypertension. Use caution when administering ALUNBRIG\nin combination with antihypertensive agents that cause bradycardia.\n\nBradycardia\n\nIn ALTA 1L, heart rates less than 50 beats per minute (bpm) occurred in 8.1%\nof patients receiving ALUNBRIG; one patient (0.7%) experienced Grade 3\nbradycardia. Monitor heart rate and blood pressure during treatment with\nALUNBRIG. For symptomatic bradycardia, withhold ALUNBRIG and review\nconcomitant medications for those known to cause bradycardia; dose reduce\nconcomitant medication or ALUNBRIG as appropriate. Discontinue ALUNBRIG for\nlife-threatening bradycardia if no contributing concomitant medication is\nidentified.\n\nVisual Disturbance\n\nIn ALTA 1L, Grade 1 or 2 adverse reactions leading to visual disturbance,\nincluding blurred vision, photophobia, photopsia, and reduced visual acuity,\nwere reported in 7.4% of patients receiving ALUNBRIG. In the ALTA study, at\nthe approved dose (90→180 mg), Grade 3 macular edema and cataract occurred\nin one patient each. Advise patients to report any visual symptoms. Withhold\nALUNBRIG and obtain an ophthalmologic evaluation in patients with new or\nworsening visual symptoms of Grade 2 or greater severity; upon recovery, dose\nreduce as appropriate. Permanently discontinue treatment with ALUNBRIG for\nGrade 4 visual disturbances.\n\nCreatine Phosphokinase (CPK) Elevation\n\nIn ALTA 1L, creatine phosphokinase (CPK) elevation occurred in 81% of patients\nwho received ALUNBRIG. The incidence of Grade 3 or 4 CPK elevation was 24%.\nDose reduction for CPK elevation occurred in 15% of patients. Advise patients\nto report any unexplained muscle pain, tenderness, or weakness. Monitor CPK\nlevels during ALUNBRIG treatment. Withhold ALUNBRIG for Grade 3 or 4 CPK\nelevation with Grade 2 or higher muscle pain or weakness. Upon resolution or\nrecovery to Grade 1 CPK elevation or baseline, resume ALUNBRIG at the same\ndose or at a reduced dose.\n\nPancreatic Enzyme Elevation\n\nIn ALTA 1L, amylase elevation occurred in 52% of patients and Grade 3 or 4\namylase elevation occurred in 6.8% of patients who received ALUNBRIG. Lipase\nelevations occurred in 59% of patients and Grade 3 or 4 lipase elevation\noccurred in 17% of patients. Monitor lipase and amylase during treatment with\nALUNBRIG. Withhold ALUNBRIG for Grade 3 or 4 pancreatic enzyme elevation. Upon\nresolution or recovery to Grade 1 or baseline, resume ALUNBRIG at the same\ndose or at a reduced dose.\n\nHepatotoxicity\n\nIn ALTA 1L, aspartate aminotransferase (AST) elevations occurred in 72% of\npatients and Grade 3 or 4 AST elevations occurred in 4.5% of patients who\nreceived ALUNBRIG. Alanine aminotransferase (ALT) elevations occurred in 52%\nof patients and Grade 3 or 4 ALT elevations occurred in 5.2% of patients. One\npatient (0.7%) had a serious adverse reaction of hepatocellular injury.\nMonitor AST, ALT and total bilirubin during treatment with ALUNBRIG,\nespecially during the first 3 months. Withhold ALUNBRIG for Grade 3 or 4\nhepatic enzyme elevation with bilirubin less than or equal to 2 × ULN. Upon\nresolution or recovery to Grade 1 or less (less than or equal to 3 × ULN) or\nto baseline, resume ALUNBRIG at a next lower dose. Permanently discontinue\nALUNBRIG for Grade 2 to 4 hepatic enzyme elevation with concurrent total\nbilirubin elevation greater than 2 times the ULN in the absence of cholestasis\nor hemolysis.\n\nHyperglycemia\n\nIn ALTA 1L, 56% of patients who received ALUNBRIG experienced new or worsening\nhyperglycemia. Grade 3 hyperglycemia, based on laboratory assessment of serum\nfasting glucose levels, occurred in 7.5% of patients. In the ALTA study, 2 of\n20 (10%) patients with diabetes or glucose intolerance at baseline required\ninitiation of insulin while receiving ALUNBRIG. Assess fasting serum glucose\nprior to initiation of ALUNBRIG and monitor periodically thereafter. Initiate\nor optimize anti-hyperglycemic medications as needed. If adequate\nhyperglycemic control cannot be achieved with optimal medical management,\nwithhold ALUNBRIG until adequate hyperglycemic control is achieved and\nconsider reducing the dose of ALUNBRIG.\n\nPhotosensitivity\n\nIn ALTA 1L, 3.7% of patients who received ALUNBRIG experienced\nphotosensitivity, with 0.7% of patients experiencing Grade 3 to 4 reactions.\nAdvise patients to limit sun exposure while taking ALUNBRIG, and for at least\n5 days after discontinuation of treatment. Advise patients, when outdoors, to\nwear protective clothing and use a broad-spectrum sunscreen (SPF ≥30) to\nhelp protect against sunburn. Based on the severity, withhold ALUNBRIG, then\nresume at the same dose, or reduce the dose, or permanently discontinue.\n\nEmbryo-Fetal Toxicity\n\nBased on its mechanism of action and findings in animals, ALUNBRIG can cause\nfetal harm when administered to pregnant women. There are no clinical data on\nthe use of ALUNBRIG in pregnant women. Advise women of the potential risk to a\nfetus.\n\nADVERSE REACTIONS\n\nThe most common adverse reactions (≥25%) with ALUNBRIG were diarrhea,\nfatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, and\ndyspnea.\n\nDRUG INTERACTIONS\n\nCYP3A Inhibitors: Avoid coadministration of ALUNBRIG with strong or moderate\nCYP3A inhibitors. If coadministration of a strong or moderate CYP3A inhibitor\nis unavoidable, reduce the dose of ALUNBRIG.\n\nCYP3A Inducers: Avoid coadministration of ALUNBRIG with strong or moderate\nCYP3A inducers. If coadministration of a moderate CYP3A inducer is\nunavoidable, increase the dose of ALUNBRIG.\n\nUSE IN SPECIFIC POPULATIONS\n\nFemales and Males of Reproductive Potential\n\nVerify pregnancy status in females of reproductive potential prior to\ninitiating ALUNBRIG. Advise females of reproductive potential to use effective\ncontraception during treatment with ALUNBRIG and for at least 4 months after\nthe final dose. Advise males with female partners of reproductive potential to\nuse effective contraception during treatment with ALUNBRIG and for at least 3\nmonths after the final dose. ALUNBRIG may cause reduced fertility in males.\n\nLactation: Advise patients not to breastfeed.\n\nHepatic Impairment: Reduce the dose of ALUNBRIG for patients with severe\nhepatic impairment.\n\nRenal Impairment: Reduce the dose of ALUNBRIG for patients with severe renal\nimpairment.\n\nTo report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A.,\nInc. at 1-844-217-6468 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.fda.gov%2Fsafety%2Fmedwatch-fda-safety-information-and-adverse-event-reporting-program&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=www.fda.gov%2Fmedwatch&index=3&md5=18979815deaf68e593a8a3799df1d1d5)\n.\n\nPlease see full Prescribing Information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.alunbrig.com%2Fsites%2Fdefault%2Ffiles%2F2022-10%2Fprescribing-information.pdf&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=Prescribing+Information&index=4&md5=d5847bdb9f64412da55c052fb69b0e12)\n.\n\nFRUZAQLA(®) (fruquintinib) IMPORTANT SAFETY INFORMATION\n\nINDICATION\n\nFRUZAQLA is indicated for the treatment of adult patients with metastatic\ncolorectal cancer (mCRC) who have been previously treated with\nfluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an\nanti-VEGF therapy, and, if RAS wild-type and medically appropriate, an\nanti-EGFR therapy.\n\nWARNINGS AND PRECAUTIONS\n\n\n * Hypertension occurred in 49% of 911 patients with mCRC treated with FRUZAQLA,\nincluding Grade 3-4 events in 19%, and hypertensive crisis in three patients\n(0.3%). Do not initiate FRUZAQLA unless blood pressure is adequately\ncontrolled. Monitor blood pressure weekly for the first month and at least\nmonthly thereafter as clinically indicated. Initiate or adjust\nanti-hypertensive therapy as appropriate. Withhold, reduce dose, or\npermanently discontinue FRUZAQLA based on severity of hypertension.\n\n\n * Hemorrhagic Events including serious, fatal events can occur with FRUZAQLA. In\n911 patients with mCRC treated with FRUZAQLA, 6% of patients experienced\ngastrointestinal hemorrhage, including 1% with a Grade ≥3 event and 2\npatients with fatal hemorrhages. Permanently discontinue FRUZAQLA in patients\nwith severe or life-threatening hemorrhage. Monitor the International\nNormalized Ratio (INR) levels in patients receiving anticoagulants.\n\n\n * Infections. FRUZAQLA can increase the risk of infections, including fatal\ninfections. In 911 patients with mCRC treated with FRUZAQLA, the most common\ninfections were urinary tract infections (6.8%), upper respiratory tract\ninfections (3.2%) and pneumonia (2.5%); fatal infections included pneumonia\n(0.4%), sepsis (0.2%), bacterial infection (0.1%), lower respiratory tract\ninfection (0.1%), and septic shock (0.1%). Withhold FRUZAQLA for Grade 3 or 4\ninfections, or worsening infection of any grade. Resume FRUZAQLA at the same\ndose when the infection has resolved.\n\n\n * Gastrointestinal Perforation occurred in patients treated with FRUZAQLA. In\n911 patients with mCRC treated with FRUZAQLA, 1.3% experienced a Grade ≥3\ngastrointestinal perforation, including one fatal event. Permanently\ndiscontinue FRUZAQLA in patients who develop gastrointestinal perforation or\nfistula.\n\n\n * Hepatotoxicity. FRUZAQLA can cause liver injury. In 911 patients with mCRC\ntreated with FRUZAQLA, 48% experienced increased ALT or AST, including Grade\n≥3 events in 5%, and fatal events in 0.2% of patients. Monitor liver\nfunction tests (ALT, AST, and bilirubin) before initiation and periodically\nthroughout treatment with FRUZAQLA. Temporarily hold and then reduce or\npermanently discontinue FRUZAQLA depending on the severity and persistence of\nhepatotoxicity as manifested by elevated liver function tests.\n\n\n * Proteinuria. FRUZAQLA can cause proteinuria. In 911 patients with mCRC treated\nwith FRUZAQLA, 36% experienced proteinuria and 2.5% of patients experienced\nGrade ≥3 events. Monitor for proteinuria before initiation and periodically\nthroughout treatment with FRUZAQLA. For proteinuria ≥2g/24 hours, withhold\nFRUZAQLA until improvement to ≤Grade 1 proteinuria and resume FRUZAQLA at a\nreduced dose. Discontinue FRUZAQLA in patients who develop nephrotic syndrome.\n\n\n * Palmar-Plantar Erythrodysesthesia (PPE) occurred in 35% of 911 patients\ntreated with FRUZAQLA, including 8% with Grade 3 events. Based on severity of\nPPE, withhold FRUZAQLA and then resume at the same or reduced dose.\n\n\n * Posterior Reversible Encephalopathy Syndrome (PRES), a syndrome of subcortical\nvasogenic edema diagnosed by characteristic finding on MRI, occurred in one of\n911 patients treated with FRUZAQLA. Perform an evaluation for PRES in any\npatient presenting with seizures, headache, visual disturbances, confusion, or\naltered mental function. Discontinue FRUZAQLA in patients who develop PRES.\n\n\n * Impaired Wound Healing. In 911 patients with mCRC treated with FRUZAQLA, 1\npatient experienced a Grade 2 event of wound dehiscence. Do not administer\nFRUZAQLA for at least 2 weeks prior to major surgery. Do not administer\nFRUZAQLA for at least 2 weeks after major surgery and until adequate wound\nhealing. The safety of resumption of FRUZAQLA after resolution of wound\nhealing complications has not been established.\n\n\n * Arterial Thromboembolic Events. In 911 patients with mCRC treated with\nFRUZAQLA, 0.8% of patients experienced an arterial thromboembolic event.\nInitiation of FRUZAQLA in patients with a recent history of thromboembolic\nevents should be carefully considered. In patients who develop arterial\nthromboembolism, discontinue FRUZAQLA.\n\n\n * Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) and No. 6 (Sunset\nYellow FCF). FRUZAQLA 1 mg capsules contain FD&C Yellow No. 5\n(tartrazine), which may cause allergic-type reactions (including bronchial\nasthma) in certain susceptible persons. FRUZAQLA 1 mg contains FD&C Yellow\nNo. 6 (sunset yellow FCF), which may cause allergic reactions.\n\n\n * Embryo-Fetal Toxicity. Based on findings in animal studies and its mechanism\nof action, FRUZAQLA can cause fetal harm when administered to pregnant women.\nAdvise pregnant women of the potential risk to a fetus.\n\nADVERSE REACTIONS\n\nThe most common adverse reactions (incidence ≥20%) following treatment with\nFRUZAQLA included hypertension, palmar-plantar erythrodysesthesia (hand-foot\nskin reactions), proteinuria, dysphonia, abdominal pain, diarrhea, and\nasthenia.\n\nDRUG INTERACTIONS\n\nAvoid concomitant administration of FRUZAQLA with strong or moderate CYP3A\ninducers.\n\nUSE IN SPECIFIC POPULATIONS\n\n\n * Lactation: Advise women not to breastfeed during treatment with FRUZAQLA and\nfor 2 weeks after the last dose.\n\n\n * Females and Males of Reproductive Potential\n\n\n * Pregnancy Testing: Verify pregnancy status of females of reproductive\npotential prior to initiating FRUZAQLA.\n\n\n * Contraception: Females of childbearing potential and males with female\npartners of childbearing potential should use effective contraception during\ntreatment and for 2 weeks after the last dose of FRUZAQLA.\n\n\n * Infertility: Advise females of reproductive potential that FRUZAQLA may cause\npost-implantation loss.\n\nTo report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at\n1-844-662-8532 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.fda.gov%2Fsafety%2Fmedwatch-fda-safety-information-and-adverse-event-reporting-program&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=www.fda.gov%2Fmedwatch&index=5&md5=fd8a8a9cf080645440ab7665eb52b8b6)\n.\n\nPlease see FRUZAQLA (fruquintinib) full Prescribing Information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftakeda.info%2FFruzaqla-Prescribing-Information&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=Prescribing+Information&index=6&md5=416a3254606853bdff03d4a134d8eba0)\n.\n\nTakeda’s Commitment to Oncology\n\nAt Takeda Oncology, we are united by our aspiration to cure cancer, with\ninspiration from patients and innovation from everywhere. Drawing on decades\nof leadership in oncology, we work to develop innovative treatments that\nenhance and extend the lives of people living with cancer. We are committed to\nensuring that patients globally can benefit from and access our portfolio of\nmedicines, while also progressing a pipeline of potential treatments for the\nfuture. Our research and development efforts are focused on advancing\nmedicines for hematologic, gastrointestinal and thoracic cancers by leveraging\nmodalities best suited to make a difference in the treatment of these\ndiseases. We complement our internal expertise and global footprint with a\nrobust network of collaborators. Together, we strive to bring life-changing\nmedicines to more patients around the world. For more information, visit\nwww.takedaoncology.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takedaoncology.com%2F&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=www.takedaoncology.com&index=7&md5=2ab871580db53a461a5dabcd1dd2a83b)\n.\n\nAbout Takeda\n\nTakeda is focused on creating better health for people and a brighter future\nfor the world. We aim to discover and deliver life-transforming treatments in\nour core therapeutic and business areas, including gastrointestinal and\ninflammation, rare diseases, plasma-derived therapies, oncology, neuroscience\nand vaccines. Together with our partners, we aim to improve the patient\nexperience and advance a new frontier of treatment options through our dynamic\nand diverse pipeline. As a leading values-based, R&D-driven\nbiopharmaceutical company headquartered in Japan, we are guided by our\ncommitment to patients, our people and the planet. Our employees in\napproximately 80 countries and regions are driven by our purpose and are\ngrounded in the values that have defined us for more than two centuries. For\nmore information, visit www.takeda.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.takeda.com&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=www.takeda.com&index=8&md5=c938357c03afbb559bbb46d97dd9ff9c)\n.\n\nImportant Notice\n\nFor the purposes of this notice, “press release” means this document, any\noral presentation, any question and answer session and any written or oral\nmaterial discussed or distributed by Takeda Pharmaceutical Company Limited\n(“Takeda”) regarding this release. This press release (including any oral\nbriefing and any question-and-answer in connection with it) is not intended\nto, and does not constitute, represent or form part of any offer, invitation\nor solicitation of any offer to purchase, otherwise acquire, subscribe for,\nexchange, sell or otherwise dispose of, any securities or the solicitation of\nany vote or approval in any jurisdiction. No shares or other securities are\nbeing offered to the public by means of this press release. No offering of\nsecurities shall be made in the United States except pursuant to registration\nunder the U.S. Securities Act of 1933, as amended, or an exemption therefrom.\nThis press release is being given (together with any further information which\nmay be provided to the recipient) on the condition that it is for use by the\nrecipient for information purposes only (and not for the evaluation of any\ninvestment, acquisition, disposal or any other transaction). Any failure to\ncomply with these restrictions may constitute a violation of applicable\nsecurities laws. The companies in which Takeda directly and indirectly owns\ninvestments are separate entities. In this press release, “Takeda” is\nsometimes used for convenience where references are made to Takeda and its\nsubsidiaries in general. Likewise, the words “we”, “us” and “our”\nare also used to refer to subsidiaries in general or to those who work for\nthem. These expressions are also used where no useful purpose is served by\nidentifying the particular company or companies.\n\nForward-Looking Statements\n\nThis press release and any materials distributed in connection with this press\nrelease may contain forward-looking statements, beliefs or opinions regarding\nTakeda’s future business, future position and results of operations,\nincluding estimates, forecasts, targets and plans for Takeda. Without\nlimitation, forward-looking statements often include words such as\n“targets”, “plans”, “believes”, “hopes”, “continues”,\n“expects”, “aims”, “intends”, “ensures”, “will”,\n“may”, “should”, “would”, “could”, “anticipates”,\n“estimates”, “projects”, “forecasts”, “outlook” or similar\nexpressions or the negative thereof. These forward-looking statements are\nbased on assumptions about many important factors, including the following,\nwhich could cause actual results to differ materially from those expressed or\nimplied by the forward-looking statements: the economic circumstances\nsurrounding Takeda’s global business, including general economic conditions\nin Japan and the United States and with respect to international trade\nrelations; competitive pressures and developments; changes to applicable laws\nand regulations, including drug pricing, tax, tariff and other trade-related\nrules; challenges inherent in new product development, including uncertainty\nof clinical success and decisions of regulatory authorities and the timing\nthereof; uncertainty of commercial success for new and existing products;\nmanufacturing difficulties or delays; fluctuations in interest and currency\nexchange rates; claims or concerns regarding the safety or efficacy of\nmarketed products or product candidates; the impact of health crises, like the\nnovel coronavirus pandemic; the success of our environmental sustainability\nefforts, in enabling us to reduce our greenhouse gas emissions or meet our\nother environmental goals; the extent to which our efforts to increase\nefficiency, productivity or cost-savings, such as the integration of digital\ntechnologies, including artificial intelligence, in our business or other\ninitiatives to restructure our operations will lead to the expected benefits;\nand other factors identified in Takeda’s most recent Annual Report on Form\n20-F and Takeda’s other reports filed with the U.S. Securities and Exchange\nCommission, available on Takeda’s website at:\nhttps://www.takeda.com/investors/sec-filings-and-security-reports/\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Fsec-filings-and-security-reports%2F&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Fsec-filings-and-security-reports%2F&index=9&md5=4748a5a71a852a58077c56535e75e3af)\nor at www.sec.gov\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=54608238&newsitemid=20260921356638&lan=en-US&anchor=www.sec.gov&index=10&md5=6c5b8c0ca77b419d3e9d69cb44d35826)\n. Takeda does not undertake to update any of the forward-looking statements\ncontained in this press release or any other forward-looking statements it may\nmake, except as required by law or stock exchange rule. Past performance is\nnot an indicator of future results and the results or statements of Takeda in\nthis press release may not be indicative of, and are not an estimate,\nforecast, guarantee or projection of Takeda’s future results.\n\nMedical Information\n\nThis press release contains information about products that may not be\navailable in all countries, or may be available under different trademarks,\nfor different indications, in different dosages, or in different strengths.\nNothing contained herein should be considered a solicitation, promotion or\nadvertisement for any prescription drugs including the ones under development.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260921356638/en/\n(https://www.businesswire.com/news/home/20260921356638/en/)\n\nMedia Relations:\n\n\n\nInvestor Relations \n\nChristopher O’Reilly\n\ntakeda.ir.contact@takeda.com \n(mailto:takeda.ir.contact@takeda.com) \n\n\nJapanese Media \n\nTsuyoshi Tada\n\ntoiawase_kouhou@takeda.co.jp \n(mailto:toiawase_kouhou@takeda.co.jp) \n\n\nU.S. and International Media \n\nHollie Wyatt\n\nhollie.wyatt@takeda.com (mailto:hollie.wyatt@takeda.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-09-22T13:30:00.386600665Z","server_sent_at_ms":1790083800386},"received_at":"2026-09-22T13:30:00.500Z","source_url":"https://www.businesswire.com/news/home/20260921356638/en/"},"analysis":{"id":"138532","press_release_id":"149839","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":["both TAK-921 and TAK-928 are investigational and not approved by FDA or any regulator","no efficacy or safety data disclosed ahead of the late-breaking presentation"],"eventType":"clinical_trial","narrative":"Takeda will present late-breaking Phase 3 G-HOPE-001 data on arcotatug tavatecan (TAK-921) in previously treated advanced gastric cancer at ESMO on October 23, which could support a regulatory filing in Japan pending final results.\n\nTwo TAK-928 presentations in NSCLC will also be featured, and Takeda is expanding the global Phase 3 MarsLight-11 study with a new non-squamous NSCLC sub-trial evaluating TAK-928 versus docetaxel.\n\nBoth compounds are licensed from Innovent, with Takeda holding worldwide rights outside Greater China for TAK-921; no efficacy data are disclosed in this release, so the October 23 presentation is the real catalyst.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Watch Takeda's late-breaking TAK-921 Phase 3 gastric cancer data at ESMO on Oct 23 — a potential Japan filing catalyst."},"keyFigures":{"drugName":"arcotatug tavatecan (TAK-921; Innovent R&D code: IBI343)","phaseOfTrial":"Phase 3","customDimensions":{"abstract":"LBA77","trial_ids":["NCT06238843 (G-HOPE-001)","NCT07217301 (MarsLight-11)"],"esmo_congress_dates":"October 23-27, 2026"}},"quotedText":"Pending evaluation of final study results, data from G-HOPE-001 could support a potential regulatory filing for this indication in Japan.","namedEntities":{"people":[{"name":"Phuong Khanh (P.K.) Morrow, M.D.","role":"Head of the Oncology Therapeutic Area Unit at Takeda"}],"products":["arcotatug tavatecan (TAK-921 / IBI343)","TAK-928 (IBI363)","ALUNBRIG (brigatinib)","FRUZAQLA (fruquintinib)","bevacizumab","docetaxel"],"companies":[{"name":"Takeda Pharmaceutical Company Limited","ticker":"4502","relationship":"filer"},{"name":"Innovent","relationship":"license and collaboration partner"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Pipeline progress announcements ahead of ESMO 2026: late-breaking Phase 3 G-HOPE-001 data for TAK-921 and Phase 3 MarsLight-11 expansion for TAK-928. No efficacy or safety results are disclosed yet; the actual data release on October 23 is the binary catalyst."},"tickerRelevance":{"others":[],"primary":"4502"},"globalImportance":30,"audienceRelevance":30,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"large-cap-pharma","eventGravity":"pipeline-preview-no-data","catalystTiming":"ESMO presentation Oct 23, 2026"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Takeda will present late-breaking Phase 3 G-HOPE-001 data on arcotatug tavatecan (TAK-921) in previously treated advanced gastric cancer at ESMO on October 23, which could support a regulatory filing in Japan pending final results.\n\nTwo TAK-928 presentations in NSCLC will also be featured, and Takeda is expanding the global Phase 3 MarsLight-11 study with a new non-squamous NSCLC sub-trial evaluating TAK-928 versus docetaxel.\n\nBoth compounds are licensed from Innovent, with Takeda holding worldwide rights outside Greater China for TAK-921; no efficacy data are disclosed in this release, so the October 23 presentation is the real catalyst.","key_figures":{"drugName":"arcotatug tavatecan (TAK-921; Innovent R&D code: IBI343)","phaseOfTrial":"Phase 3","customDimensions":{"abstract":"LBA77","trial_ids":["NCT06238843 (G-HOPE-001)","NCT07217301 (MarsLight-11)"],"esmo_congress_dates":"October 23-27, 2026"}},"named_entities":{"people":[{"name":"Phuong Khanh (P.K.) Morrow, M.D.","role":"Head of the Oncology Therapeutic Area Unit at Takeda"}],"products":["arcotatug tavatecan (TAK-921 / IBI343)","TAK-928 (IBI363)","ALUNBRIG (brigatinib)","FRUZAQLA (fruquintinib)","bevacizumab","docetaxel"],"companies":[{"name":"Takeda Pharmaceutical Company Limited","ticker":"4502","relationship":"filer"},{"name":"Innovent","relationship":"license and collaboration partner"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-22T17:05:50.909Z","global_importance":30,"audience_relevance":30,"importance_components":{"tickerTier":"large-cap-pharma","eventGravity":"pipeline-preview-no-data","catalystTiming":"ESMO presentation Oct 23, 2026"}},"durationMs":10240,"modelName":"glm-5.3-flash"}}