{"success":true,"data":{"pressRelease":{"id":"173266","rtpr_id":"nBw23CM2ra-20261019","ticker":"GSK","exchange":"LSE","all_tickers":["GSK"],"title":"Jemperli (dostarlimab-gxly) approved in US as first and only immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancer","author":"Business Wire","published_at":"2026-10-19T22:18:00.073Z","article_body":"Jemperli (dostarlimab-gxly) approved in US as first and only immunotherapy for\nadults with MSI-H/dMMR locally advanced rectal cancer\n\n\n * Approval based on AZUR-1 data showing clinically significant proportion of\nparticipants with no detectable signs of cancer one year or more after\ntreatment\n\n * No disease recurrences reported among responders after median follow up of\nmore than two years\n\n * Jemperli monotherapy could help eligible patients avoid chemotherapy,\nradiation and surgery\n\nGSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration\n(FDA) has approved Jemperli (dostarlimab-gxly) as the first and only\nimmunotherapy for adults with stage II and III microsatellite instability-high\n(MSI-H)/mismatch repair deficient (dMMR) locally advanced rectal cancer under\nthe accelerated approval pathway.\n\nCurrent standard of treatment for locally advanced rectal cancer includes\nchemotherapy, radiation and surgery(1), but these can have lasting\nconsequences, including bowel, urinary and sexual dysfunction, secondary\ncancers and infertility(2,3). For patients with MSI-H/dMMR tumors, a biomarker\nfound in around 5-10% of rectal cancers(4), Jemperli monotherapy could help\navoid these interventions.\n\nTony Wood, Chief Scientific Officer, GSK, said: “Today, Jemperli becomes the\nfirst and only approved immunotherapy for adults in the US with MSI-H/dMMR\nlocally advanced rectal cancer. For decades, treatment has relied on\nchemotherapy, radiation and surgery. This approval offers a new treatment\napproach and represents an important step towards more personalized care for\nthese patients.”\n\nDr. Andrea Cercek, MD, Principal Investigator of AZUR-1, Section Head of\nColorectal Cancer and Co-Director of the Center for Young Onset Colorectal and\nGastrointestinal Cancer, Memorial Sloan Kettering Cancer Center, said: “The\nAZUR-1 results demonstrate the potential for a fundamentally different\ntreatment approach in this biomarker-defined patient population, and today’s\napproval means MSI-H/dMMR patients can now access a licensed treatment\ntailored to the biology of their disease.”\n\nMichael Sapienza, CEO, Colorectal Cancer Alliance, said: “People facing\nrectal cancer are often thinking not only about treating their disease, but\nalso worrying about what life will look like afterwards. The possibility of\navoiding chemotherapy, radiation and surgery represents a meaningful advance\nfor patients and their families. Biomarker testing at diagnosis will be\nessential to identifying patients who may be eligible for this treatment and\nhelping them understand their options.”\n\nApproval was based on data from the phase II AZUR-1 trial. The study met its\nprimary objective, demonstrating a clinically significant proportion of\nparticipants achieved sustained clinical complete responses at 12 months\n(cCR12), with data continuing to mature.\n\nInvestigator-assessed data, a clinically relevant endpoint, showed 68% of\nevaluable patients (98/144; 95% CI: 60%, 76%) achieved cCR12. In an\nexploratory analysis, 76% (110/144; 95% CI: 69%, 83%) of evaluable patients\nhad no evidence of cancer one year or more after treatment. This includes 68%\n(98/144) (95% CI: 60%, 76%) of patients who reached cCR12 without surgery,\nplus other participants (n=12) who had their complete response confirmed\nthrough tissue analysis after surgery (pathological complete response, or\npCR). No disease recurrences have been reported among responders to date,\nafter a median follow up of more than two years.\n\nData on the primary objective, cCR12 assessed by Independent Central Review,\ncontinue to mature. 47% (54/116) (95% CI: 37%, 56%) of evaluable patients have\nachieved cCR12. An additional 38 participants who are still progressing\nthrough to 12 month follow up have already achieved a clinical complete\nresponse.\n\nThe safety profile of Jemperli was generally consistent with its established\nprofile across solid tumors. Serious adverse reactions occurred in 20% of\npatients receiving Jemperli, and the most common adverse reactions were\nfatigue (32%), rash (22%), diarrhea (18%) and pruritus (17%). Jemperli was\npermanently discontinued due to adverse reactions in 3% of patients.\n\nFull data from the AZUR-1 interim analysis will be presented at the European\nSociety for Medical Oncology (ESMO) Congress in October 2026.\n\nJemperli has received FDA Fast Track and Breakthrough Therapy designations for\nthis indication. The application was also granted Priority Review and received\na National Priority Voucher, resulting in an accelerated approval ahead of the\nPDUFA date.\n\nThe supplemental Biologics License Application (sBLA) is being reviewed under\nProject Orbis, an FDA Oncology Center of Excellence initiative that enables\nconcurrent review by international health authorities. Regulatory reviews are\nongoing in participating countries.\n\nAbout stage II/III MSI-H/dMMR locally advanced rectal cancer\n\nAround 5–10% of rectal cancers are microsatellite instability-high (MSI-H)\nor mismatch repair-deficient (dMMR)(4). These tumors have a specific genetic\ncharacteristic where they are unable to properly repair DNA damage, leading to\nan accumulation of mutations. This unique biological feature often makes them\nhighly responsive to immunotherapies like dostarlimab-gxly(5,6). These\nbiomarkers are commonly found in colorectal, endometrial and other\ngastrointestinal cancers, but can also be present in other solid tumors(7).\n\nAbout AZUR-1\n\nAZUR-1 is a global, open-label, single-arm, registrational phase II trial\nevaluating dostarlimab-gxly monotherapy in patients (n=154) with previously\nuntreated stage II and III MSI-H/dMMR locally advanced rectal cancer. The\ntrial was designed to assess clinical complete responses sustained for 12\nmonths (cCR12) as determined by Independent Central Review, and to determine\nwhether dostarlimab-gxly alone could enable patients to avoid chemotherapy,\nradiation and surgery. Additional efficacy outcomes include cCR12 based on\ninvestigator assessment and objective response rate (ORR), defined as patients\nwho achieved cCR, clinical near-complete response, or clinical partial\nresponse as their best overall response. Patients received nine cycles of\ndostarlimab-gxly over six months, administered as a 500mg intravenous infusion\nevery three weeks. The safety and tolerability profile of dostarlimab-gxly was\ngenerally consistent with its well-characterized safety profile observed\nacross solid tumors. Serious adverse reactions occurred in 20% of patients\nreceiving Jemperli and treatment was permanently discontinued due to adverse\nreactions in 3% of patients. The most common adverse reactions (≥15%) were\nfatigue, rash, diarrhea and pruritus.\n\nAbout Jemperli (dostarlimab-gxly)\n\nJemperli, a programmed death receptor-1 (PD-1)-blocking antibody, plays an\nimportant role in GSK’s immune-oncology research and development program. A\nrobust clinical trial program includes studies of Jemperli alone and in\ncombination with other therapies in gynecologic, colorectal, and head and neck\ncancers, as well as where there are opportunities for transformational\noutcomes.\n\nJemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc.,\nunder a collaboration and exclusive license agreement signed in March 2014.\nUnder this agreement, GSK is responsible for the ongoing research,\ndevelopment, commercialization and manufacturing of Jemperli.\n\nMore information about the product and its currently approved indications is\navailable at EU product information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Fproduct-information%2Fjemperli-epar-product-information_en.pdf&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=EU+product+information&index=1&md5=8cdbb8be004874db5cbb1c7c9a31f7ff)\n(8) and US product information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fgskpro.com%2Fcontent%2Fdam%2Fglobal%2Fhcpportal%2Fen_US%2FPrescribing_Information%2FJemperli%2Fpdf%2FJEMPERLI-PI-MG.PDF&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=US+product+information&index=2&md5=2f7b4ba04e84d34ef8f40d2c12ac49c5)\n(9).\n\nIndications and Important Safety Information for JEMPERLI (dostarlimab-gxly)\n\n\n * JEMPERLI, in combination with carboplatin and paclitaxel, followed by JEMPERLI\nas a single agent, is indicated for the treatment of adult patients with\nprimary advanced or recurrent endometrial cancer (EC).\n\n * JEMPERLI, as a single agent, is indicated for the treatment of adult patients\nwith mismatch repair deficient (dMMR) recurrent or advanced:\n\n\n* EC, as determined by an FDA-authorized test, that has progressed on or\nfollowing prior treatment with a platinum-containing regimen in any setting\nand are not candidates for curative surgery or radiation, or\n\n * solid tumors, as determined by an FDA-authorized test, that have progressed on\nor following prior treatment and who have no satisfactory alternative\ntreatment options. This indication is approved under accelerated approval\nbased on tumor response rate and durability of response. Continued approval\nfor this indication may be contingent upon verification and description of\nclinical benefit in a confirmatory trial(s).\n\n\n\n\n * JEMPERLI, as a single agent, is indicated for the treatment of adult patients\nwith Stage II/III, locally advanced rectal cancer (LARC) that is\nmicrosatellite instability-high (MSI-H) or dMMR, as determined by an\nFDA-authorized test for solid tumors. This indication is approved under\naccelerated approval based on sustained clinical complete response for 12\nmonths. The long-term risk of relapse is unknown, with additional follow-up\nexpected. Continued approval for this indication may be contingent upon\nverification and description of clinical benefit in a confirmatory trial(s).\n\nImportant Safety Information\n\nSevere and Fatal Immune-Mediated Adverse Reactions\n\n\n * Immune-mediated adverse reactions, which can be severe or fatal, can occur in\nany organ system or tissue and can occur at any time during or after treatment\nwith a PD-1/PD-L1–blocking antibody, including JEMPERLI.\n\n * Monitor closely for signs and symptoms of immune-mediated adverse reactions.\nEvaluate liver enzymes, creatinine, and thyroid function tests at baseline and\nperiodically during treatment. For suspected immune-mediated adverse\nreactions, initiate appropriate workup to exclude alternative etiologies,\nincluding infection. Institute medical management promptly, including\nspecialty consultation as appropriate.\n\n * Based on the severity of the adverse reaction, withhold or permanently\ndiscontinue JEMPERLI. In general, if JEMPERLI requires interruption or\ndiscontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day\nprednisone or equivalent) until improvement to ≤Grade 1. Upon improvement to\n≤Grade 1, initiate corticosteroid taper and continue to taper over at least\n1 month. Consider administration of other systemic immunosuppressants in\npatients whose immune-mediated adverse reaction is not controlled with\ncorticosteroids.\n\nImmune-Mediated Pneumonitis\n\n\n * JEMPERLI can cause immune-mediated pneumonitis, which can be fatal. In\npatients treated with other PD-1/PD-L1–blocking antibodies, the incidence of\npneumonitis is higher in patients who have received prior thoracic radiation.\nPneumonitis occurred in 2% (15/759) of patients receiving JEMPERLI as a single\nagent, including Grade 2 (1.2%), Grade 3 (0.7%), and Grade 4 (0.1%)\npneumonitis.\n\nImmune-Mediated Colitis\n\n\n * Colitis occurred in 1.2% (9/759) of patients receiving JEMPERLI as a single\nagent, including Grade 2 (0.7%) and Grade 3 (0.5%) adverse reactions.\nCytomegalovirus infection/reactivation have occurred in patients with\ncorticosteroid-refractory immune-mediated colitis. In such cases, consider\nrepeating infectious workup to exclude alternative etiologies.\n\nImmune-Mediated Hepatitis\n\n\n * JEMPERLI can cause immune-mediated hepatitis, which can be fatal. Grade 3\nhepatitis occurred in 0.5% (4/759) of patients receiving JEMPERLI as a single\nagent.\n\nImmune-Mediated Endocrinopathies\n\n\n * Adrenal Insufficiency\n\n\n* Adrenal insufficiency occurred in 1.1% (8/759) of patients receiving\nJEMPERLI\nas a single agent, including Grade 2 (0.4%) and Grade 3 (0.7%). For Grade 2 or\nhigher adrenal insufficiency, initiate symptomatic treatment per institutional\nguidelines, including hormone replacement as clinically indicated. Withhold or\npermanently discontinue JEMPERLI depending on severity.\n\n\n\n\n * Hypophysitis\n\n\n* JEMPERLI can cause immune-mediated hypophysitis. Grade 3 hypophysitis\noccurred\nin 0.4% (1/241) of patients receiving JEMPERLI in combination with carboplatin\nand paclitaxel. Grade 2 hypophysitis occurred in 0.3% (2/759) of patients\nreceiving JEMPERLI as a single agent. Initiate hormone replacement as\nclinically indicated. Withhold or permanently discontinue JEMPERLI depending\non severity.\n\n\n\n\n * Thyroid Disorders\n\n\n* Grade 2 thyroiditis occurred in 0.4% (3/759) of patients receiving JEMPERLI\nas\na single agent. Grade 2 hypothyroidism occurred in 12% (30/241) of patients\nreceiving JEMPERLI in combination with carboplatin and paclitaxel. Grade 2\nhypothyroidism occurred in 8% (58/759) of patients receiving JEMPERLI as a\nsingle agent. Hyperthyroidism occurred in 3.3% (8/241) of patients receiving\nJEMPERLI in combination with carboplatin and paclitaxel, including Grade 2\n(2.9%) and Grade 3 (0.4%). Hyperthyroidism occurred in 2.2% (17/759) of\npatients receiving JEMPERLI as a single agent, including Grade 2 (2.1%) and\nGrade 3 (0.1%). Initiate thyroid hormone replacement or medical management of\nhyperthyroidism as clinically indicated. Withhold or permanently discontinue\nJEMPERLI depending on severity.\n\n\n\n\n * Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis\n\n\n* JEMPERLI can cause type 1 diabetes mellitus, which can present with diabetic\nketoacidosis. Grade 3 type 1 diabetes mellitus occurred in 0.4% (1/241) of\npatients receiving JEMPERLI in combination with carboplatin and paclitaxel.\nGrade 3 type 1 diabetes mellitus occurred in 0.1% (1/759) of patients\nreceiving JEMPERLI as a single agent. Monitor patients for hyperglycemia or\nother signs and symptoms of diabetes. Initiate treatment with insulin as\nclinically indicated. Withhold or permanently discontinue JEMPERLI depending\non severity.\n\n\n\n\nImmune-Mediated Nephritis with Renal Dysfunction\n\n\n * JEMPERLI can cause immune-mediated nephritis, which can be fatal. Grade 2\nnephritis, including tubulointerstitial nephritis, occurred in 0.4% (3/759) of\npatients receiving JEMPERLI as a single agent.\n\nImmune-Mediated Dermatologic Adverse Reactions\n\n\n * JEMPERLI can cause immune-mediated rash or dermatitis. Bullous and exfoliative\ndermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal\nnecrolysis (TEN), and drug rash with eosinophilia and systemic symptoms\n(DRESS), have occurred with PD-1/PD-L1–blocking antibodies. One patient\nreceiving JEMPERLI experienced Grade 3 SJS, which resolved. Topical emollients\nand/or topical corticosteroids may be adequate to treat mild to moderate\nnon-bullous/exfoliative rashes. Withhold or permanently discontinue JEMPERLI\ndepending on severity.\n\nOther Immune-Mediated Adverse Reactions\n\n\n * The following clinically significant immune-mediated adverse reactions\noccurred in <1% of the 759 patients treated with JEMPERLI or were reported\nwith the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases\nhave been reported for some of these adverse reactions.\n\n\n* Nervous System: Meningitis, encephalitis, myelitis and demyelination,\nmyasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, nerve\nparesis, autoimmune neuropathy\n\n * Cardiac/Vascular: Myocarditis, pericarditis, vasculitis\n\n * Ocular: Uveitis, iritis, other ocular inflammatory toxicities. Some cases can\nbe associated with retinal detachment. Various grades of visual impairment to\ninclude blindness can occur\n\n * Gastrointestinal: Pancreatitis, including increases in serum amylase and\nlipase levels, gastritis, duodenitis\n\n * Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis\nand associated sequelae including renal failure, arthritis, polymyalgia\nrheumatica\n\n * Endocrine: Hypoparathyroidism\n\n * Hematologic/Immune: Autoimmune hemolytic anemia, aplastic anemia,\nhemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome,\nhistiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis,\nimmune thrombocytopenia, solid organ transplant rejection, other transplant\n(including corneal graft) rejection\n\n * Other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap\nSyndrome, reported as the co-occurrence of either two or all three adverse\nreactions.\n\n\n\n\nInfusion-Related Reactions\n\n\n * Severe or life-threatening infusion-related reactions have been reported with\nPD-1/PD-L1–blocking antibodies. Severe infusion-related reactions (Grade 3)\noccurred in 0.1% (1/759) of patients receiving JEMPERLI as a single agent.\nMonitor patients for signs and symptoms of infusion-related reactions.\nInterrupt or slow the rate of infusion or permanently discontinue JEMPERLI\nbased on severity of reaction.\n\nComplications of Allogeneic HSCT\n\n\n * Fatal and other serious complications can occur in patients who receive\nallogeneic hematopoietic stem cell transplantation (HSCT) before or after\ntreatment with a PD-1/PD-L1–blocking antibody, which may occur despite\nintervening therapy. Monitor patients closely for transplant-related\ncomplications and intervene promptly.\n\nEmbryo-Fetal Toxicity and Lactation\n\n\n * Based on its mechanism of action, JEMPERLI can cause fetal harm. Advise\npregnant women of the potential risk to a fetus. Advise women of reproductive\npotential to use effective contraception during treatment with JEMPERLI and\nfor 4 months after their last dose. Because of the potential for serious\nadverse reactions from JEMPERLI in a breastfed child, advise women not to\nbreastfeed during treatment with JEMPERLI and for 4 months after their last\ndose.\n\nCommon Adverse Reactions\n\nThe most common adverse reactions (≥20%), including laboratory\nabnormalities, in patients with EC who received JEMPERLI in combination with\ncarboplatin and paclitaxel were decreased hemoglobin, increased creatinine,\nperipheral neuropathy, decreased white blood cell count, fatigue, nausea,\nalopecia, decreased platelets, increased glucose, decreased lymphocytes,\ndecreased magnesium, decreased neutrophils, increased AST, arthralgia, rash,\nconstipation, diarrhea, increased ALT, decreased potassium, decreased albumin,\ndecreased sodium, increased alkaline phosphatase, abdominal pain, dyspnea,\ndecreased appetite, increased amylase, decreased phosphate, urinary tract\ninfection, and vomiting.\n\nThe most common adverse reactions (≥20%) in patients with dMMR EC who\nreceived JEMPERLI as a single agent were fatigue/asthenia, anemia, nausea,\ndiarrhea, constipation, vomiting, and rash. The most common Grade 3 or 4\nlaboratory abnormalities (>2%) were decreased lymphocytes, decreased\nsodium, increased alanine aminotransferase, increased creatinine, decreased\nneutrophils, decreased albumin, and increased alkaline phosphatase.\n\nThe most common adverse reactions (≥20%) in patients with dMMR solid tumors\nwho received JEMPERLI as a single agent were fatigue/asthenia, anemia,\ndiarrhea, and nausea. The most common Grade 3 or 4 laboratory abnormalities\n(≥2%) were decreased lymphocytes, decreased sodium, increased alkaline\nphosphatase, and decreased albumin.\n\nThe most common adverse reactions (≥15%) in patients with MSI-H/dMMR LARC\nwho received JEMPERLI as a single agent were fatigue, rash, diarrhea, and\npruritus. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were\ndecreased lymphocytes, decreased hemoglobin, and increased AST.\n\nPlease see full Prescribing Information, including Medication Guide.\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fgskpro.com%2Fcontent%2Fdam%2Fglobal%2Fhcpportal%2Fen_US%2FPrescribing_Information%2FJemperli%2Fpdf%2FJEMPERLI-PI-MG.PDF&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=Prescribing+Information%2C+including+Medication+Guide.&index=3&md5=87be69d81a2decbdaba52c4088f50da4)\n\nGSK in oncology\n\nOur ambition in oncology is to help increase overall quality of life, maximize\nsurvival and change the course of disease, expanding from our current focus on\nblood and women’s cancers into lung and gastrointestinal cancers, as well as\nother solid tumors. This includes accelerating priority programs such as\nantibody-drug conjugates Ris-Rez targeting B7-H3 and Mo-Rez targeting B7-H4,\nand velzatinib, a highly selective KIT tyrosine kinase inhibitor.\n\nAbout GSK\n\nGSK is a global biopharma company with a purpose to unite science, technology,\nand talent to get ahead of disease together. Find out more at www.us.gsk.com.\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.us.gsk.com%2F&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=www.us.gsk.com.&index=4&md5=545f165d0e2a41e3c50e65a8a3066182)\n\nCautionary statement regarding forward-looking statements\n\nGSK cautions investors that any forward-looking statements or projections made\nby GSK, including those made in this announcement, are subject to risks and\nuncertainties that may cause actual results to differ materially from those\nprojected. Such factors include, but are not limited to, those described in\nthe “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2025,\nand GSK’s Q2 Results for 2026.\n\nRegistered in England & Wales:\n\nNo. 3888792\n\nRegistered Office:\n\n79 New Oxford Street London\n\nWC1A 1DG\n\nReferences:\n\n\n 1. Cercek A, Lumish M, Sinopoli J, et al. PD-1 blockade in mismatch\nrepair–deficient, locally advanced rectal cancer. N Engl J Med 2022; 386:\n2363-76.\n\n 2. Negro, S. et al. (2025) ‘Quality of life in rectal cancer treatments: a\nsystematic review’, Cancers, 17(14), 2310. Available at: \nhttps://www.mdpi.com/2072-6694/17/14/2310\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.mdpi.com%2F2072-6694%2F17%2F14%2F2310&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=https%3A%2F%2Fwww.mdpi.com%2F2072-6694%2F17%2F14%2F2310&index=5&md5=936348417a0df0890d7908f53b11e7be)\n\n 3. Neibart, S.S. et al. (2020) ‘Quality of life after radiotherapy for rectal\ncancer’, Current Colorectal Cancer Reports, 16(1), pp. 1–10. Available at:\n\nhttps://pmc.ncbi.nlm.nih.gov/articles/PMC7336840/\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fpmc.ncbi.nlm.nih.gov%2Farticles%2FPMC7336840%2F&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=https%3A%2F%2Fpmc.ncbi.nlm.nih.gov%2Farticles%2FPMC7336840%2F&index=6&md5=fcdcf686eae80312b1f4ab6da0b11769)\n\n 4. Cercek A, et al. Mismatch Repair-Deficient Rectal Cancer and Resistance to\nNeoadjuvant Chemotherapy. Clin Cancer Res. 2020 Jul 1;26(13):3271-3279. doi:\n1158/1078-0432.CCR-19-3728. Epub 2020 Mar 6. PMID: 32144135; PMCID:\nPMC7348681.\n\n 5. Andre T, Berton D, Curigliano G, et al. Antitumor Activity and Safety of\nDostarlimab Monotherapy in Patients With Mismatch Repair Deficient Solid\nTumors: A Nonrandomized Controlled Trial. JAMA Netw Open. 2023;6(11):e2341165.\ndoi:10.1001/jamanetworkopen.2023.41165.\n\n 6. Le DT, et al. PD-1 blockade in tumors with mismatch repair deficiency. N Engl\nJ Med. 2015;372(26):2509-2520.\n\n 7. National Cancer Institute at the National Institutes of Health. Definition of\nmismatch repair deficiency. Accessed September 2026. Available at: \nhttps://www.cancer.gov/publications/dictionaries/cancer-terms/def/mismatch-repair-deficiency\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.cancer.gov%2Fpublications%2Fdictionaries%2Fcancer-terms%2Fdef%2Fmismatch-repair-deficiency&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=https%3A%2F%2Fwww.cancer.gov%2Fpublications%2Fdictionaries%2Fcancer-terms%2Fdef%2Fmismatch-repair-deficiency&index=7&md5=23df6fa99c62ac235826f4c897e2054b)\n\n 8. JEMPERLI (dostarlimab) Summary of Product Characteristics. GlaxoSmithKline\n(Ireland) Limited. Available at: \nhttps://www.ema.europa.eu/en/medicines/human/EPAR/jemperli.\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fmedicines%2Fhuman%2FEPAR%2Fjemperli&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fmedicines%2Fhuman%2FEPAR%2Fjemperli.&index=8&md5=a9a8a49674f399f801b6c64313782d68)\n\nAccessed October 2026.\n\n 9. JEMPERLI (dostarlimab-gxly) prescribing information. GlaxoSmithKline.\nAvailable at: \nhttps://gskpro.com/en-us/products/jemperli/.\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fgskpro.com%2Fen-us%2Fproducts%2Fjemperli%2F&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=https%3A%2F%2Fgskpro.com%2Fen-us%2Fproducts%2Fjemperli%2F.&index=9&md5=575f23131d93292c743c40116a643e80)\n\nAccessed October 2026.\n\nMemorial Sloan Kettering Cancer Center Disclosure: Dr Cercek has financial\ninterests related to GSK.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261019827202/en/\n(https://www.businesswire.com/news/home/20261019827202/en/)\n\nGSK inquiries \n\nMedia:\n\nTim Foley +44 (0) 20 8047 5502 (London)\n\nSarah Clements +44 (0) 20 8047 5502 (London)\n\nKathleen Quinn +1 202 603 5003 (Washington DC)\n\nAlison Hunt +1 540 742 3391 (Washington DC)\n\nStephanie Caccomo +1 202 893 2840 (Washington DC)\n\n\n\nInvestor Relations:\n\nJames Dodwell +44 (0) 7881 269066 (London)\n\nMick Readey +44 (0) 7990 339653 (London)\n\nJoanna Tuplin +44 (0) 7788 351650 (London)\n\nSam Piper +44 (0) 7824 525779 (London)\n\nDan Smith +44 (0) 7823 523885 (London)\n\nJeff McLaughlin +1 215 751 7002 (Philadelphia)\n\nFrannie DeFranco +1 215 751 3126 (Philadelphia)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw23CM2ra-20261019","title":"Jemperli (dostarlimab-gxly) approved in US as first and only immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancer","author":"Business Wire","ticker":"GSK","created":"2026-10-19T22:18:00.073Z","tickers":["GSK"],"exchange":"LSE","article_body":"Jemperli (dostarlimab-gxly) approved in US as first and only immunotherapy for\nadults with MSI-H/dMMR locally advanced rectal cancer\n\n\n * Approval based on AZUR-1 data showing clinically significant proportion of\nparticipants with no detectable signs of cancer one year or more after\ntreatment\n\n * No disease recurrences reported among responders after median follow up of\nmore than two years\n\n * Jemperli monotherapy could help eligible patients avoid chemotherapy,\nradiation and surgery\n\nGSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration\n(FDA) has approved Jemperli (dostarlimab-gxly) as the first and only\nimmunotherapy for adults with stage II and III microsatellite instability-high\n(MSI-H)/mismatch repair deficient (dMMR) locally advanced rectal cancer under\nthe accelerated approval pathway.\n\nCurrent standard of treatment for locally advanced rectal cancer includes\nchemotherapy, radiation and surgery(1), but these can have lasting\nconsequences, including bowel, urinary and sexual dysfunction, secondary\ncancers and infertility(2,3). For patients with MSI-H/dMMR tumors, a biomarker\nfound in around 5-10% of rectal cancers(4), Jemperli monotherapy could help\navoid these interventions.\n\nTony Wood, Chief Scientific Officer, GSK, said: “Today, Jemperli becomes the\nfirst and only approved immunotherapy for adults in the US with MSI-H/dMMR\nlocally advanced rectal cancer. For decades, treatment has relied on\nchemotherapy, radiation and surgery. This approval offers a new treatment\napproach and represents an important step towards more personalized care for\nthese patients.”\n\nDr. Andrea Cercek, MD, Principal Investigator of AZUR-1, Section Head of\nColorectal Cancer and Co-Director of the Center for Young Onset Colorectal and\nGastrointestinal Cancer, Memorial Sloan Kettering Cancer Center, said: “The\nAZUR-1 results demonstrate the potential for a fundamentally different\ntreatment approach in this biomarker-defined patient population, and today’s\napproval means MSI-H/dMMR patients can now access a licensed treatment\ntailored to the biology of their disease.”\n\nMichael Sapienza, CEO, Colorectal Cancer Alliance, said: “People facing\nrectal cancer are often thinking not only about treating their disease, but\nalso worrying about what life will look like afterwards. The possibility of\navoiding chemotherapy, radiation and surgery represents a meaningful advance\nfor patients and their families. Biomarker testing at diagnosis will be\nessential to identifying patients who may be eligible for this treatment and\nhelping them understand their options.”\n\nApproval was based on data from the phase II AZUR-1 trial. The study met its\nprimary objective, demonstrating a clinically significant proportion of\nparticipants achieved sustained clinical complete responses at 12 months\n(cCR12), with data continuing to mature.\n\nInvestigator-assessed data, a clinically relevant endpoint, showed 68% of\nevaluable patients (98/144; 95% CI: 60%, 76%) achieved cCR12. In an\nexploratory analysis, 76% (110/144; 95% CI: 69%, 83%) of evaluable patients\nhad no evidence of cancer one year or more after treatment. This includes 68%\n(98/144) (95% CI: 60%, 76%) of patients who reached cCR12 without surgery,\nplus other participants (n=12) who had their complete response confirmed\nthrough tissue analysis after surgery (pathological complete response, or\npCR). No disease recurrences have been reported among responders to date,\nafter a median follow up of more than two years.\n\nData on the primary objective, cCR12 assessed by Independent Central Review,\ncontinue to mature. 47% (54/116) (95% CI: 37%, 56%) of evaluable patients have\nachieved cCR12. An additional 38 participants who are still progressing\nthrough to 12 month follow up have already achieved a clinical complete\nresponse.\n\nThe safety profile of Jemperli was generally consistent with its established\nprofile across solid tumors. Serious adverse reactions occurred in 20% of\npatients receiving Jemperli, and the most common adverse reactions were\nfatigue (32%), rash (22%), diarrhea (18%) and pruritus (17%). Jemperli was\npermanently discontinued due to adverse reactions in 3% of patients.\n\nFull data from the AZUR-1 interim analysis will be presented at the European\nSociety for Medical Oncology (ESMO) Congress in October 2026.\n\nJemperli has received FDA Fast Track and Breakthrough Therapy designations for\nthis indication. The application was also granted Priority Review and received\na National Priority Voucher, resulting in an accelerated approval ahead of the\nPDUFA date.\n\nThe supplemental Biologics License Application (sBLA) is being reviewed under\nProject Orbis, an FDA Oncology Center of Excellence initiative that enables\nconcurrent review by international health authorities. Regulatory reviews are\nongoing in participating countries.\n\nAbout stage II/III MSI-H/dMMR locally advanced rectal cancer\n\nAround 5–10% of rectal cancers are microsatellite instability-high (MSI-H)\nor mismatch repair-deficient (dMMR)(4). These tumors have a specific genetic\ncharacteristic where they are unable to properly repair DNA damage, leading to\nan accumulation of mutations. This unique biological feature often makes them\nhighly responsive to immunotherapies like dostarlimab-gxly(5,6). These\nbiomarkers are commonly found in colorectal, endometrial and other\ngastrointestinal cancers, but can also be present in other solid tumors(7).\n\nAbout AZUR-1\n\nAZUR-1 is a global, open-label, single-arm, registrational phase II trial\nevaluating dostarlimab-gxly monotherapy in patients (n=154) with previously\nuntreated stage II and III MSI-H/dMMR locally advanced rectal cancer. The\ntrial was designed to assess clinical complete responses sustained for 12\nmonths (cCR12) as determined by Independent Central Review, and to determine\nwhether dostarlimab-gxly alone could enable patients to avoid chemotherapy,\nradiation and surgery. Additional efficacy outcomes include cCR12 based on\ninvestigator assessment and objective response rate (ORR), defined as patients\nwho achieved cCR, clinical near-complete response, or clinical partial\nresponse as their best overall response. Patients received nine cycles of\ndostarlimab-gxly over six months, administered as a 500mg intravenous infusion\nevery three weeks. The safety and tolerability profile of dostarlimab-gxly was\ngenerally consistent with its well-characterized safety profile observed\nacross solid tumors. Serious adverse reactions occurred in 20% of patients\nreceiving Jemperli and treatment was permanently discontinued due to adverse\nreactions in 3% of patients. The most common adverse reactions (≥15%) were\nfatigue, rash, diarrhea and pruritus.\n\nAbout Jemperli (dostarlimab-gxly)\n\nJemperli, a programmed death receptor-1 (PD-1)-blocking antibody, plays an\nimportant role in GSK’s immune-oncology research and development program. A\nrobust clinical trial program includes studies of Jemperli alone and in\ncombination with other therapies in gynecologic, colorectal, and head and neck\ncancers, as well as where there are opportunities for transformational\noutcomes.\n\nJemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc.,\nunder a collaboration and exclusive license agreement signed in March 2014.\nUnder this agreement, GSK is responsible for the ongoing research,\ndevelopment, commercialization and manufacturing of Jemperli.\n\nMore information about the product and its currently approved indications is\navailable at EU product information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Fproduct-information%2Fjemperli-epar-product-information_en.pdf&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=EU+product+information&index=1&md5=8cdbb8be004874db5cbb1c7c9a31f7ff)\n(8) and US product information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fgskpro.com%2Fcontent%2Fdam%2Fglobal%2Fhcpportal%2Fen_US%2FPrescribing_Information%2FJemperli%2Fpdf%2FJEMPERLI-PI-MG.PDF&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=US+product+information&index=2&md5=2f7b4ba04e84d34ef8f40d2c12ac49c5)\n(9).\n\nIndications and Important Safety Information for JEMPERLI (dostarlimab-gxly)\n\n\n * JEMPERLI, in combination with carboplatin and paclitaxel, followed by JEMPERLI\nas a single agent, is indicated for the treatment of adult patients with\nprimary advanced or recurrent endometrial cancer (EC).\n\n * JEMPERLI, as a single agent, is indicated for the treatment of adult patients\nwith mismatch repair deficient (dMMR) recurrent or advanced:\n\n\n* EC, as determined by an FDA-authorized test, that has progressed on or\nfollowing prior treatment with a platinum-containing regimen in any setting\nand are not candidates for curative surgery or radiation, or\n\n * solid tumors, as determined by an FDA-authorized test, that have progressed on\nor following prior treatment and who have no satisfactory alternative\ntreatment options. This indication is approved under accelerated approval\nbased on tumor response rate and durability of response. Continued approval\nfor this indication may be contingent upon verification and description of\nclinical benefit in a confirmatory trial(s).\n\n\n\n\n * JEMPERLI, as a single agent, is indicated for the treatment of adult patients\nwith Stage II/III, locally advanced rectal cancer (LARC) that is\nmicrosatellite instability-high (MSI-H) or dMMR, as determined by an\nFDA-authorized test for solid tumors. This indication is approved under\naccelerated approval based on sustained clinical complete response for 12\nmonths. The long-term risk of relapse is unknown, with additional follow-up\nexpected. Continued approval for this indication may be contingent upon\nverification and description of clinical benefit in a confirmatory trial(s).\n\nImportant Safety Information\n\nSevere and Fatal Immune-Mediated Adverse Reactions\n\n\n * Immune-mediated adverse reactions, which can be severe or fatal, can occur in\nany organ system or tissue and can occur at any time during or after treatment\nwith a PD-1/PD-L1–blocking antibody, including JEMPERLI.\n\n * Monitor closely for signs and symptoms of immune-mediated adverse reactions.\nEvaluate liver enzymes, creatinine, and thyroid function tests at baseline and\nperiodically during treatment. For suspected immune-mediated adverse\nreactions, initiate appropriate workup to exclude alternative etiologies,\nincluding infection. Institute medical management promptly, including\nspecialty consultation as appropriate.\n\n * Based on the severity of the adverse reaction, withhold or permanently\ndiscontinue JEMPERLI. In general, if JEMPERLI requires interruption or\ndiscontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day\nprednisone or equivalent) until improvement to ≤Grade 1. Upon improvement to\n≤Grade 1, initiate corticosteroid taper and continue to taper over at least\n1 month. Consider administration of other systemic immunosuppressants in\npatients whose immune-mediated adverse reaction is not controlled with\ncorticosteroids.\n\nImmune-Mediated Pneumonitis\n\n\n * JEMPERLI can cause immune-mediated pneumonitis, which can be fatal. In\npatients treated with other PD-1/PD-L1–blocking antibodies, the incidence of\npneumonitis is higher in patients who have received prior thoracic radiation.\nPneumonitis occurred in 2% (15/759) of patients receiving JEMPERLI as a single\nagent, including Grade 2 (1.2%), Grade 3 (0.7%), and Grade 4 (0.1%)\npneumonitis.\n\nImmune-Mediated Colitis\n\n\n * Colitis occurred in 1.2% (9/759) of patients receiving JEMPERLI as a single\nagent, including Grade 2 (0.7%) and Grade 3 (0.5%) adverse reactions.\nCytomegalovirus infection/reactivation have occurred in patients with\ncorticosteroid-refractory immune-mediated colitis. In such cases, consider\nrepeating infectious workup to exclude alternative etiologies.\n\nImmune-Mediated Hepatitis\n\n\n * JEMPERLI can cause immune-mediated hepatitis, which can be fatal. Grade 3\nhepatitis occurred in 0.5% (4/759) of patients receiving JEMPERLI as a single\nagent.\n\nImmune-Mediated Endocrinopathies\n\n\n * Adrenal Insufficiency\n\n\n* Adrenal insufficiency occurred in 1.1% (8/759) of patients receiving\nJEMPERLI\nas a single agent, including Grade 2 (0.4%) and Grade 3 (0.7%). For Grade 2 or\nhigher adrenal insufficiency, initiate symptomatic treatment per institutional\nguidelines, including hormone replacement as clinically indicated. Withhold or\npermanently discontinue JEMPERLI depending on severity.\n\n\n\n\n * Hypophysitis\n\n\n* JEMPERLI can cause immune-mediated hypophysitis. Grade 3 hypophysitis\noccurred\nin 0.4% (1/241) of patients receiving JEMPERLI in combination with carboplatin\nand paclitaxel. Grade 2 hypophysitis occurred in 0.3% (2/759) of patients\nreceiving JEMPERLI as a single agent. Initiate hormone replacement as\nclinically indicated. Withhold or permanently discontinue JEMPERLI depending\non severity.\n\n\n\n\n * Thyroid Disorders\n\n\n* Grade 2 thyroiditis occurred in 0.4% (3/759) of patients receiving JEMPERLI\nas\na single agent. Grade 2 hypothyroidism occurred in 12% (30/241) of patients\nreceiving JEMPERLI in combination with carboplatin and paclitaxel. Grade 2\nhypothyroidism occurred in 8% (58/759) of patients receiving JEMPERLI as a\nsingle agent. Hyperthyroidism occurred in 3.3% (8/241) of patients receiving\nJEMPERLI in combination with carboplatin and paclitaxel, including Grade 2\n(2.9%) and Grade 3 (0.4%). Hyperthyroidism occurred in 2.2% (17/759) of\npatients receiving JEMPERLI as a single agent, including Grade 2 (2.1%) and\nGrade 3 (0.1%). Initiate thyroid hormone replacement or medical management of\nhyperthyroidism as clinically indicated. Withhold or permanently discontinue\nJEMPERLI depending on severity.\n\n\n\n\n * Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis\n\n\n* JEMPERLI can cause type 1 diabetes mellitus, which can present with diabetic\nketoacidosis. Grade 3 type 1 diabetes mellitus occurred in 0.4% (1/241) of\npatients receiving JEMPERLI in combination with carboplatin and paclitaxel.\nGrade 3 type 1 diabetes mellitus occurred in 0.1% (1/759) of patients\nreceiving JEMPERLI as a single agent. Monitor patients for hyperglycemia or\nother signs and symptoms of diabetes. Initiate treatment with insulin as\nclinically indicated. Withhold or permanently discontinue JEMPERLI depending\non severity.\n\n\n\n\nImmune-Mediated Nephritis with Renal Dysfunction\n\n\n * JEMPERLI can cause immune-mediated nephritis, which can be fatal. Grade 2\nnephritis, including tubulointerstitial nephritis, occurred in 0.4% (3/759) of\npatients receiving JEMPERLI as a single agent.\n\nImmune-Mediated Dermatologic Adverse Reactions\n\n\n * JEMPERLI can cause immune-mediated rash or dermatitis. Bullous and exfoliative\ndermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal\nnecrolysis (TEN), and drug rash with eosinophilia and systemic symptoms\n(DRESS), have occurred with PD-1/PD-L1–blocking antibodies. One patient\nreceiving JEMPERLI experienced Grade 3 SJS, which resolved. Topical emollients\nand/or topical corticosteroids may be adequate to treat mild to moderate\nnon-bullous/exfoliative rashes. Withhold or permanently discontinue JEMPERLI\ndepending on severity.\n\nOther Immune-Mediated Adverse Reactions\n\n\n * The following clinically significant immune-mediated adverse reactions\noccurred in <1% of the 759 patients treated with JEMPERLI or were reported\nwith the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases\nhave been reported for some of these adverse reactions.\n\n\n* Nervous System: Meningitis, encephalitis, myelitis and demyelination,\nmyasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, nerve\nparesis, autoimmune neuropathy\n\n * Cardiac/Vascular: Myocarditis, pericarditis, vasculitis\n\n * Ocular: Uveitis, iritis, other ocular inflammatory toxicities. Some cases can\nbe associated with retinal detachment. Various grades of visual impairment to\ninclude blindness can occur\n\n * Gastrointestinal: Pancreatitis, including increases in serum amylase and\nlipase levels, gastritis, duodenitis\n\n * Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis\nand associated sequelae including renal failure, arthritis, polymyalgia\nrheumatica\n\n * Endocrine: Hypoparathyroidism\n\n * Hematologic/Immune: Autoimmune hemolytic anemia, aplastic anemia,\nhemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome,\nhistiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis,\nimmune thrombocytopenia, solid organ transplant rejection, other transplant\n(including corneal graft) rejection\n\n * Other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap\nSyndrome, reported as the co-occurrence of either two or all three adverse\nreactions.\n\n\n\n\nInfusion-Related Reactions\n\n\n * Severe or life-threatening infusion-related reactions have been reported with\nPD-1/PD-L1–blocking antibodies. Severe infusion-related reactions (Grade 3)\noccurred in 0.1% (1/759) of patients receiving JEMPERLI as a single agent.\nMonitor patients for signs and symptoms of infusion-related reactions.\nInterrupt or slow the rate of infusion or permanently discontinue JEMPERLI\nbased on severity of reaction.\n\nComplications of Allogeneic HSCT\n\n\n * Fatal and other serious complications can occur in patients who receive\nallogeneic hematopoietic stem cell transplantation (HSCT) before or after\ntreatment with a PD-1/PD-L1–blocking antibody, which may occur despite\nintervening therapy. Monitor patients closely for transplant-related\ncomplications and intervene promptly.\n\nEmbryo-Fetal Toxicity and Lactation\n\n\n * Based on its mechanism of action, JEMPERLI can cause fetal harm. Advise\npregnant women of the potential risk to a fetus. Advise women of reproductive\npotential to use effective contraception during treatment with JEMPERLI and\nfor 4 months after their last dose. Because of the potential for serious\nadverse reactions from JEMPERLI in a breastfed child, advise women not to\nbreastfeed during treatment with JEMPERLI and for 4 months after their last\ndose.\n\nCommon Adverse Reactions\n\nThe most common adverse reactions (≥20%), including laboratory\nabnormalities, in patients with EC who received JEMPERLI in combination with\ncarboplatin and paclitaxel were decreased hemoglobin, increased creatinine,\nperipheral neuropathy, decreased white blood cell count, fatigue, nausea,\nalopecia, decreased platelets, increased glucose, decreased lymphocytes,\ndecreased magnesium, decreased neutrophils, increased AST, arthralgia, rash,\nconstipation, diarrhea, increased ALT, decreased potassium, decreased albumin,\ndecreased sodium, increased alkaline phosphatase, abdominal pain, dyspnea,\ndecreased appetite, increased amylase, decreased phosphate, urinary tract\ninfection, and vomiting.\n\nThe most common adverse reactions (≥20%) in patients with dMMR EC who\nreceived JEMPERLI as a single agent were fatigue/asthenia, anemia, nausea,\ndiarrhea, constipation, vomiting, and rash. The most common Grade 3 or 4\nlaboratory abnormalities (>2%) were decreased lymphocytes, decreased\nsodium, increased alanine aminotransferase, increased creatinine, decreased\nneutrophils, decreased albumin, and increased alkaline phosphatase.\n\nThe most common adverse reactions (≥20%) in patients with dMMR solid tumors\nwho received JEMPERLI as a single agent were fatigue/asthenia, anemia,\ndiarrhea, and nausea. The most common Grade 3 or 4 laboratory abnormalities\n(≥2%) were decreased lymphocytes, decreased sodium, increased alkaline\nphosphatase, and decreased albumin.\n\nThe most common adverse reactions (≥15%) in patients with MSI-H/dMMR LARC\nwho received JEMPERLI as a single agent were fatigue, rash, diarrhea, and\npruritus. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were\ndecreased lymphocytes, decreased hemoglobin, and increased AST.\n\nPlease see full Prescribing Information, including Medication Guide.\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fgskpro.com%2Fcontent%2Fdam%2Fglobal%2Fhcpportal%2Fen_US%2FPrescribing_Information%2FJemperli%2Fpdf%2FJEMPERLI-PI-MG.PDF&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=Prescribing+Information%2C+including+Medication+Guide.&index=3&md5=87be69d81a2decbdaba52c4088f50da4)\n\nGSK in oncology\n\nOur ambition in oncology is to help increase overall quality of life, maximize\nsurvival and change the course of disease, expanding from our current focus on\nblood and women’s cancers into lung and gastrointestinal cancers, as well as\nother solid tumors. This includes accelerating priority programs such as\nantibody-drug conjugates Ris-Rez targeting B7-H3 and Mo-Rez targeting B7-H4,\nand velzatinib, a highly selective KIT tyrosine kinase inhibitor.\n\nAbout GSK\n\nGSK is a global biopharma company with a purpose to unite science, technology,\nand talent to get ahead of disease together. Find out more at www.us.gsk.com.\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.us.gsk.com%2F&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=www.us.gsk.com.&index=4&md5=545f165d0e2a41e3c50e65a8a3066182)\n\nCautionary statement regarding forward-looking statements\n\nGSK cautions investors that any forward-looking statements or projections made\nby GSK, including those made in this announcement, are subject to risks and\nuncertainties that may cause actual results to differ materially from those\nprojected. Such factors include, but are not limited to, those described in\nthe “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2025,\nand GSK’s Q2 Results for 2026.\n\nRegistered in England & Wales:\n\nNo. 3888792\n\nRegistered Office:\n\n79 New Oxford Street London\n\nWC1A 1DG\n\nReferences:\n\n\n 1. Cercek A, Lumish M, Sinopoli J, et al. PD-1 blockade in mismatch\nrepair–deficient, locally advanced rectal cancer. N Engl J Med 2022; 386:\n2363-76.\n\n 2. Negro, S. et al. (2025) ‘Quality of life in rectal cancer treatments: a\nsystematic review’, Cancers, 17(14), 2310. Available at: \nhttps://www.mdpi.com/2072-6694/17/14/2310\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.mdpi.com%2F2072-6694%2F17%2F14%2F2310&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=https%3A%2F%2Fwww.mdpi.com%2F2072-6694%2F17%2F14%2F2310&index=5&md5=936348417a0df0890d7908f53b11e7be)\n\n 3. Neibart, S.S. et al. (2020) ‘Quality of life after radiotherapy for rectal\ncancer’, Current Colorectal Cancer Reports, 16(1), pp. 1–10. Available at:\n\nhttps://pmc.ncbi.nlm.nih.gov/articles/PMC7336840/\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fpmc.ncbi.nlm.nih.gov%2Farticles%2FPMC7336840%2F&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=https%3A%2F%2Fpmc.ncbi.nlm.nih.gov%2Farticles%2FPMC7336840%2F&index=6&md5=fcdcf686eae80312b1f4ab6da0b11769)\n\n 4. Cercek A, et al. Mismatch Repair-Deficient Rectal Cancer and Resistance to\nNeoadjuvant Chemotherapy. Clin Cancer Res. 2020 Jul 1;26(13):3271-3279. doi:\n1158/1078-0432.CCR-19-3728. Epub 2020 Mar 6. PMID: 32144135; PMCID:\nPMC7348681.\n\n 5. Andre T, Berton D, Curigliano G, et al. Antitumor Activity and Safety of\nDostarlimab Monotherapy in Patients With Mismatch Repair Deficient Solid\nTumors: A Nonrandomized Controlled Trial. JAMA Netw Open. 2023;6(11):e2341165.\ndoi:10.1001/jamanetworkopen.2023.41165.\n\n 6. Le DT, et al. PD-1 blockade in tumors with mismatch repair deficiency. N Engl\nJ Med. 2015;372(26):2509-2520.\n\n 7. National Cancer Institute at the National Institutes of Health. Definition of\nmismatch repair deficiency. Accessed September 2026. Available at: \nhttps://www.cancer.gov/publications/dictionaries/cancer-terms/def/mismatch-repair-deficiency\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.cancer.gov%2Fpublications%2Fdictionaries%2Fcancer-terms%2Fdef%2Fmismatch-repair-deficiency&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=https%3A%2F%2Fwww.cancer.gov%2Fpublications%2Fdictionaries%2Fcancer-terms%2Fdef%2Fmismatch-repair-deficiency&index=7&md5=23df6fa99c62ac235826f4c897e2054b)\n\n 8. JEMPERLI (dostarlimab) Summary of Product Characteristics. GlaxoSmithKline\n(Ireland) Limited. Available at: \nhttps://www.ema.europa.eu/en/medicines/human/EPAR/jemperli.\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fmedicines%2Fhuman%2FEPAR%2Fjemperli&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fmedicines%2Fhuman%2FEPAR%2Fjemperli.&index=8&md5=a9a8a49674f399f801b6c64313782d68)\n\nAccessed October 2026.\n\n 9. JEMPERLI (dostarlimab-gxly) prescribing information. GlaxoSmithKline.\nAvailable at: \nhttps://gskpro.com/en-us/products/jemperli/.\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fgskpro.com%2Fen-us%2Fproducts%2Fjemperli%2F&esheet=54624761&newsitemid=20261019827202&lan=en-US&anchor=https%3A%2F%2Fgskpro.com%2Fen-us%2Fproducts%2Fjemperli%2F.&index=9&md5=575f23131d93292c743c40116a643e80)\n\nAccessed October 2026.\n\nMemorial Sloan Kettering Cancer Center Disclosure: Dr Cercek has financial\ninterests related to GSK.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261019827202/en/\n(https://www.businesswire.com/news/home/20261019827202/en/)\n\nGSK inquiries \n\nMedia:\n\nTim Foley +44 (0) 20 8047 5502 (London)\n\nSarah Clements +44 (0) 20 8047 5502 (London)\n\nKathleen Quinn +1 202 603 5003 (Washington DC)\n\nAlison Hunt +1 540 742 3391 (Washington DC)\n\nStephanie Caccomo +1 202 893 2840 (Washington DC)\n\n\n\nInvestor Relations:\n\nJames Dodwell +44 (0) 7881 269066 (London)\n\nMick Readey +44 (0) 7990 339653 (London)\n\nJoanna Tuplin +44 (0) 7788 351650 (London)\n\nSam Piper +44 (0) 7824 525779 (London)\n\nDan Smith +44 (0) 7823 523885 (London)\n\nJeff McLaughlin +1 215 751 7002 (Philadelphia)\n\nFrannie DeFranco +1 215 751 3126 (Philadelphia)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-10-19T22:18:00.144309605Z","server_sent_at_ms":1792448280144},"received_at":"2026-10-19T22:18:00.300Z","source_url":"https://www.businesswire.com/news/home/20261019827202/en/"},"analysis":{"id":"161369","press_release_id":"173266","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":["accelerated approval contingent on verification in confirmatory trial(s)","primary endpoint data from Independent Central Review still maturing (47% vs 68% investigator-assessed)"],"eventType":"fda_approval","narrative":"The FDA approved GSK's Jemperli (dostarlimab-gxly) as the first and only immunotherapy for adults with stage II/III MSI-H/dMMR locally advanced rectal cancer under the accelerated approval pathway.\n\nThe approval is based on the phase II AZUR-1 trial, where 68% of evaluable patients achieved a sustained clinical complete response at 12 months by investigator assessment, with no disease recurrences reported among responders after a median follow-up of more than two years.\n\nJemperli monotherapy could allow eligible patients to avoid chemotherapy, radiation and surgery, though the indication is limited to the 5-10% of rectal cancers that are MSI-H/dMMR. Continued approval is contingent on confirmatory trial verification, and the indication is under accelerated approval.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"First-ever organ-preservation immunotherapy approval in rectal cancer extends Jemperli's label, though the niche biomarker population limits near-term revenue impact for a mega-cap."},"keyFigures":{"drugName":"Jemperli (dostarlimab-gxly)","phaseOfTrial":"Phase II","customDimensions":{"trial_name":"AZUR-1","approval_pathway":"accelerated approval","median_follow_up":"more than two years","biomarker_prevalence":"5-10% of rectal cancers","discontinuation_rate":"3%","cCR12_independent_review":"47% (54/116)","serious_adverse_reactions":"20%","cCR12_investigator_assessed":"68% (98/144)","no_evidence_of_cancer_1yr_plus":"76% (110/144)"}},"quotedText":"Today, Jemperli becomes the first and only approved immunotherapy for adults in the US with MSI-H/dMMR locally advanced rectal cancer.","namedEntities":{"people":[{"name":"Tony Wood","role":"Chief Scientific Officer, GSK"},{"name":"Dr. Andrea Cercek","role":"Principal Investigator of AZUR-1, Memorial Sloan Kettering Cancer Center"},{"name":"Michael Sapienza","role":"CEO, Colorectal Cancer Alliance"}],"products":["Jemperli (dostarlimab-gxly)"],"companies":[{"name":"GSK plc","ticker":"GSK","relationship":"filer/marketer"},{"name":"AnaptysBio, Inc.","relationship":"discoverer of Jemperli"},{"name":"TESARO, Inc.","relationship":"licensee under 2014 collaboration agreement"},{"name":"Memorial Sloan Kettering Cancer Center","relationship":"trial site"},{"name":"Colorectal Cancer Alliance","relationship":"patient advocacy organization"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"FDA approval of Jemperli as the first and only immunotherapy for MSI-H/dMMR locally advanced rectal cancer expands the drug's label into a new indication. Positive for GSK's oncology franchise, though the addressable population (5-10% of rectal cancers) is a modest share of a mega-cap's revenue base."},"tickerRelevance":{"others":[],"primary":"GSK"},"globalImportance":45,"audienceRelevance":55,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"mega-cap","eventGravity":"FDA label expansion, first-in-class indication","populationSize":"niche (5-10% of rectal cancers)","householdBrandBoost":true,"revenueMaterialityToGSK":"low-to-moderate"}},"event_type":"fda_approval","event_type_secondary":["clinical_trial"],"sentiment":"bullish","material_impact_score":4,"narrative":"The FDA approved GSK's Jemperli (dostarlimab-gxly) as the first and only immunotherapy for adults with stage II/III MSI-H/dMMR locally advanced rectal cancer under the accelerated approval pathway.\n\nThe approval is based on the phase II AZUR-1 trial, where 68% of evaluable patients achieved a sustained clinical complete response at 12 months by investigator assessment, with no disease recurrences reported among responders after a median follow-up of more than two years.\n\nJemperli monotherapy could allow eligible patients to avoid chemotherapy, radiation and surgery, though the indication is limited to the 5-10% of rectal cancers that are MSI-H/dMMR. Continued approval is contingent on confirmatory trial verification, and the indication is under accelerated approval.","key_figures":{"drugName":"Jemperli (dostarlimab-gxly)","phaseOfTrial":"Phase II","customDimensions":{"trial_name":"AZUR-1","approval_pathway":"accelerated approval","median_follow_up":"more than two years","biomarker_prevalence":"5-10% of rectal cancers","discontinuation_rate":"3%","cCR12_independent_review":"47% (54/116)","serious_adverse_reactions":"20%","cCR12_investigator_assessed":"68% (98/144)","no_evidence_of_cancer_1yr_plus":"76% (110/144)"}},"named_entities":{"people":[{"name":"Tony Wood","role":"Chief Scientific Officer, GSK"},{"name":"Dr. Andrea Cercek","role":"Principal Investigator of AZUR-1, Memorial Sloan Kettering Cancer Center"},{"name":"Michael Sapienza","role":"CEO, Colorectal Cancer Alliance"}],"products":["Jemperli (dostarlimab-gxly)"],"companies":[{"name":"GSK plc","ticker":"GSK","relationship":"filer/marketer"},{"name":"AnaptysBio, Inc.","relationship":"discoverer of Jemperli"},{"name":"TESARO, Inc.","relationship":"licensee under 2014 collaboration agreement"},{"name":"Memorial Sloan Kettering Cancer Center","relationship":"trial site"},{"name":"Colorectal Cancer Alliance","relationship":"patient advocacy organization"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-19T22:18:06.277Z","global_importance":45,"audience_relevance":55,"importance_components":{"tickerTier":"mega-cap","eventGravity":"FDA label expansion, first-in-class indication","populationSize":"niche (5-10% of rectal cancers)","householdBrandBoost":true,"revenueMaterialityToGSK":"low-to-moderate"}},"durationMs":5955,"modelName":"glm-5.3-flashx"}}