{"success":true,"data":{"pressRelease":{"id":"173034","rtpr_id":"nGNX13dm5K-20261019","ticker":"ANAB","exchange":"NASDAQ","all_tickers":["ANAB"],"title":"Jemperli (dostarlimab) Approved in the U.S. as First and Only Immunotherapy for Adults with MSI-H/dMMR Locally Advanced Rectal Cancer","author":"Globe Newswire","published_at":"2026-10-19T18:18:16.095Z","article_body":"* Approval based on AZUR-1 data showing significant proportion of participants\nwith no detectable signs of cancer one year or more after treatment \n* No disease recurrences reported among responders after median follow up of\nmore than 2 years\n* Jemperli monotherapy could help eligible patients avoid chemotherapy,\nradiation and surgery\n* GSK to present full data from the AZUR-1 interim analysis as a late-breaking\nabstract at ESMO Congress 2026 in Madrid, Spain on October 25, 2026\nSAN DIEGO, Oct. 19, 2026 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB),\na company focused on managing the financial collaborations for Jemperli with\nTesaro, a GSK company, and Quimilza (imsidolimab) with Vanda, today announced\nthat GSK has received U.S. Food and Drug Administration (FDA) approval for\nJemperli (dostarlimab) as the first and only immunotherapy for adults with\nstage II and III microsatellite instability-high (MSI-H)/ mismatch repair\ndeficient (dMMR) locally advanced rectal cancer.\n\nJemperli received FDA Fast Track and Breakthrough Therapy designations for\nthis indication. The application was also granted Priority Review and received\nthe National Priority Voucher, resulting in an accelerated approval ahead of\nthe February 2027 PDUFA date.\n\nThis approval is supported by data from the AZUR-1 trial. The study met its\nprimary objective, demonstrating a significant proportion of participants\nachieved sustained clinical complete responses at 12 months (cCR12), with data\ncontinuing 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\nGSK plans to present full data from the AZUR-1 interim analysis as a\nlate-breaking abstract at ESMO Congress 2026 in Madrid, Spain on October 25,\n2026.\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\nbiomarker found in around 5-10% of rectal cancers, Jemperli monotherapy could\nhelp avoid these interventions.(4)\n\nThe AZUR-1 sBLA is being reviewed under Project Orbis, an FDA Oncology Center\nof Excellence initiative that enables concurrent review by international\nhealth authorities. Regulatory reviews are ongoing in participating countries.\n\nAbout Jemperli (dostarlimab)\n\nJemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds\nto the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1\nand PD-L2. In the United States, Jemperli is currently approved for\nendometrial cancer, rectal cancer and dMMR solid tumors, and is currently\nbeing studied as monotherapy in colon cancer and head and neck squamous cell\ncarcinoma.\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 conducting ongoing research, development,\ncommercialization, and manufacturing of Jemperli.\n\nMore information about the product and its currently approved indications is\navailable at U.S. product information\n(https://www.globenewswire.com/Tracker?data=5w-RrJJ1T9KPIYyKL7nOmu0Tvs_b0Z4OrQuevhOoozZZPyNu1QPS4MfEi5LcTe9gaOBlAc-KR3eT5yCITt2ZVhFjsxlQ70JKdJSR7lyJOL3zTgn_QrTzltqsRhb58hjdttxf5wuHwGwomgz1Y--a7lhiJ7CxBXasbOVkqL0OhGLNeE9e3Onc9UQcxZDVLOGfy8pFsClMK_bWF-317XKzijDXD-7_wIVZiN4a7l2OfKE=)\nand EU product information\n(https://www.globenewswire.com/Tracker?data=DWsioEzMP6IwlnVGrA5bHfKnw3uIQU3c8TQdoQsg4cSbR82TnKzjNbzfcC5Jq2LnaXzB8nzX8EZehjh-9yR1Qras2YObg_0X1kVlziHPWI5L1b38ZQlwwRLjUnlwqLqixTV0C__ISB9XEhvcH2D9DxjneWymkUGETNEHHv8aYgyK7JG5J9vJPpXKA7ebk2Pd7pvVb0X80RcMSsHNxMXirQ==).\n\nAbout Anaptys\n\nAnaptys manages the financial collaborations for Jemperli with GSK and\nQuimilza with Vanda, with a focus on protecting and returning the value of its\nroyalties to shareholders. To learn more, visit www.AnaptysBio.com or follow\nus on LinkedIn\n(https://www.globenewswire.com/Tracker?data=wdRGqFDTRbLnQ07jXF1Uv9ndaVzfBZEJ_KfmWQCg9i_jGZkuUEXaY6JMogZKV6KtxoZqtOl7HTcXnwuFXaSf1Fa3UF4P2GsNYokfCV1sfV8=).\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements within the meaning of\nthe “safe harbor” provisions of the Private Securities Litigation Reform\nAct of 1995, including, but not limited to future commercial and regulatory\ndevelopments for Jemperli and Quimilza; and future royalty amounts. Statements\nincluding words such as “plan,” “continue,” “expect,” or\n“ongoing” and statements in the future tense are forward-looking\nstatements. These forward-looking statements involve risks and uncertainties,\nas well as assumptions, which, if they do not fully materialize or prove\nincorrect, could cause its results to differ materially from those expressed\nor implied by such forward-looking statements. Forward-looking statements are\nsubject to risks and uncertainties that may cause the company’s actual\nactivities or results to differ significantly from those expressed in any\nforward-looking statement, including risks and uncertainties related to\ncommercial success of the Company’s licensed products, the company’s\nability to protect its financial collaborations and return value to its\nshareholders, the company’s ability to operate efficiently with a limited\nstaff, and other risks and uncertainties described under the heading “Risk\nFactors” in documents the company files from time to time with the\nSecurities and Exchange Commission. These forward-looking statements speak\nonly as of the date of this press release, and the company undertakes no\nobligation to revise or update any forward-looking statements to reflect\nevents or circumstances after the date hereof.\n\nContact:\nChris Murphy\nChief Financial Officer\ninvestors@anaptysbio.com\n\n__________________\n1. 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.\n2. 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\n3. Neibart, S.S. et al. (2020) ‘Quality of life after radiotherapy for\nrectal cancer’, Current Colorectal Cancer Reports, 16(1), pp. 1–10.\nAvailable at: https://pmc.ncbi.nlm.nih.gov/articles/PMC7336840/\n4. 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(https://www.globenewswire.com/NewsRoom/AttachmentNg/eb223f66-e7e0-4e0a-94e7-a3f7a06b13ab)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX13dm5K-20261019","title":"Jemperli (dostarlimab) Approved in the U.S. as First and Only Immunotherapy for Adults with MSI-H/dMMR Locally Advanced Rectal Cancer","author":"Globe Newswire","ticker":"ANAB","created":"2026-10-19T18:18:16.095Z","tickers":["ANAB"],"exchange":"NASDAQ","article_body":"* Approval based on AZUR-1 data showing significant proportion of participants\nwith no detectable signs of cancer one year or more after treatment \n* No disease recurrences reported among responders after median follow up of\nmore than 2 years\n* Jemperli monotherapy could help eligible patients avoid chemotherapy,\nradiation and surgery\n* GSK to present full data from the AZUR-1 interim analysis as a late-breaking\nabstract at ESMO Congress 2026 in Madrid, Spain on October 25, 2026\nSAN DIEGO, Oct. 19, 2026 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB),\na company focused on managing the financial collaborations for Jemperli with\nTesaro, a GSK company, and Quimilza (imsidolimab) with Vanda, today announced\nthat GSK has received U.S. Food and Drug Administration (FDA) approval for\nJemperli (dostarlimab) as the first and only immunotherapy for adults with\nstage II and III microsatellite instability-high (MSI-H)/ mismatch repair\ndeficient (dMMR) locally advanced rectal cancer.\n\nJemperli received FDA Fast Track and Breakthrough Therapy designations for\nthis indication. The application was also granted Priority Review and received\nthe National Priority Voucher, resulting in an accelerated approval ahead of\nthe February 2027 PDUFA date.\n\nThis approval is supported by data from the AZUR-1 trial. The study met its\nprimary objective, demonstrating a significant proportion of participants\nachieved sustained clinical complete responses at 12 months (cCR12), with data\ncontinuing 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\nGSK plans to present full data from the AZUR-1 interim analysis as a\nlate-breaking abstract at ESMO Congress 2026 in Madrid, Spain on October 25,\n2026.\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\nbiomarker found in around 5-10% of rectal cancers, Jemperli monotherapy could\nhelp avoid these interventions.(4)\n\nThe AZUR-1 sBLA is being reviewed under Project Orbis, an FDA Oncology Center\nof Excellence initiative that enables concurrent review by international\nhealth authorities. Regulatory reviews are ongoing in participating countries.\n\nAbout Jemperli (dostarlimab)\n\nJemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds\nto the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1\nand PD-L2. In the United States, Jemperli is currently approved for\nendometrial cancer, rectal cancer and dMMR solid tumors, and is currently\nbeing studied as monotherapy in colon cancer and head and neck squamous cell\ncarcinoma.\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 conducting ongoing research, development,\ncommercialization, and manufacturing of Jemperli.\n\nMore information about the product and its currently approved indications is\navailable at U.S. product information\n(https://www.globenewswire.com/Tracker?data=5w-RrJJ1T9KPIYyKL7nOmu0Tvs_b0Z4OrQuevhOoozZZPyNu1QPS4MfEi5LcTe9gaOBlAc-KR3eT5yCITt2ZVhFjsxlQ70JKdJSR7lyJOL3zTgn_QrTzltqsRhb58hjdttxf5wuHwGwomgz1Y--a7lhiJ7CxBXasbOVkqL0OhGLNeE9e3Onc9UQcxZDVLOGfy8pFsClMK_bWF-317XKzijDXD-7_wIVZiN4a7l2OfKE=)\nand EU product information\n(https://www.globenewswire.com/Tracker?data=DWsioEzMP6IwlnVGrA5bHfKnw3uIQU3c8TQdoQsg4cSbR82TnKzjNbzfcC5Jq2LnaXzB8nzX8EZehjh-9yR1Qras2YObg_0X1kVlziHPWI5L1b38ZQlwwRLjUnlwqLqixTV0C__ISB9XEhvcH2D9DxjneWymkUGETNEHHv8aYgyK7JG5J9vJPpXKA7ebk2Pd7pvVb0X80RcMSsHNxMXirQ==).\n\nAbout Anaptys\n\nAnaptys manages the financial collaborations for Jemperli with GSK and\nQuimilza with Vanda, with a focus on protecting and returning the value of its\nroyalties to shareholders. To learn more, visit www.AnaptysBio.com or follow\nus on LinkedIn\n(https://www.globenewswire.com/Tracker?data=wdRGqFDTRbLnQ07jXF1Uv9ndaVzfBZEJ_KfmWQCg9i_jGZkuUEXaY6JMogZKV6KtxoZqtOl7HTcXnwuFXaSf1Fa3UF4P2GsNYokfCV1sfV8=).\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements within the meaning of\nthe “safe harbor” provisions of the Private Securities Litigation Reform\nAct of 1995, including, but not limited to future commercial and regulatory\ndevelopments for Jemperli and Quimilza; and future royalty amounts. Statements\nincluding words such as “plan,” “continue,” “expect,” or\n“ongoing” and statements in the future tense are forward-looking\nstatements. These forward-looking statements involve risks and uncertainties,\nas well as assumptions, which, if they do not fully materialize or prove\nincorrect, could cause its results to differ materially from those expressed\nor implied by such forward-looking statements. Forward-looking statements are\nsubject to risks and uncertainties that may cause the company’s actual\nactivities or results to differ significantly from those expressed in any\nforward-looking statement, including risks and uncertainties related to\ncommercial success of the Company’s licensed products, the company’s\nability to protect its financial collaborations and return value to its\nshareholders, the company’s ability to operate efficiently with a limited\nstaff, and other risks and uncertainties described under the heading “Risk\nFactors” in documents the company files from time to time with the\nSecurities and Exchange Commission. These forward-looking statements speak\nonly as of the date of this press release, and the company undertakes no\nobligation to revise or update any forward-looking statements to reflect\nevents or circumstances after the date hereof.\n\nContact:\nChris Murphy\nChief Financial Officer\ninvestors@anaptysbio.com\n\n__________________\n1. 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.\n2. 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\n3. Neibart, S.S. et al. (2020) ‘Quality of life after radiotherapy for\nrectal cancer’, Current Colorectal Cancer Reports, 16(1), pp. 1–10.\nAvailable at: https://pmc.ncbi.nlm.nih.gov/articles/PMC7336840/\n4. 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(https://www.globenewswire.com/NewsRoom/AttachmentNg/eb223f66-e7e0-4e0a-94e7-a3f7a06b13ab)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-19T18:18:16.130101212Z","server_sent_at_ms":1792433896130},"received_at":"2026-10-19T18:18:16.181Z","source_url":null},"analysis":{"id":"161143","press_release_id":"173034","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["Central-review cCR12 (47%) is the primary endpoint and data are still maturing; the higher 68% figure is investigator-assessed","ANAB's benefit is indirect -- royalty economics depend on GSK's commercial execution and uptake in a 5-10% biomarker subset"],"eventType":"fda_approval","narrative":"GSK received FDA approval for Jemperli (dostarlimab) as the first and only immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancer -- a new indication for the antibody discovered by AnaptysBio.\n\nAnaptysBio holds royalty rights to Jemperli, so each approval expands the product's addressable market and ANAB's future royalty stream, even though GSK books the sales.\n\nApproval came ahead of the February 2027 PDUFA date under Priority Review with Fast Track and Breakthrough Therapy designations, supported by AZUR-1 data showing 68% of evaluable patients achieving sustained clinical complete responses at 12 months with no disease recurrences after a median follow-up of more than two years.\n\nGSK will present full AZUR-1 interim data as a late-breaking abstract at ESMO 2026 in Madrid on October 25.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"First-and-only immunotherapy approval in rectal cancer expands Jemperli's label -- a direct royalty tailwind for ANAB ahead of GSK's ESMO data presentation."},"keyFigures":{"drugName":"Jemperli (dostarlimab)","phaseOfTrial":"AZUR-1 pivotal trial (interim analysis)","customDimensions":{"pdufa_date":"February 2027 (approval ahead of PDUFA date)","ccr12_central_review":"47% (54/116)","serious_adverse_reactions":"20%","ccr12_investigator_assessed":"68% (98/144)","msi_h_rectal_cancer_prevalence":"5-10% of rectal cancers","no_evidence_of_cancer_1yr_plus":"76% (110/144)"}},"quotedText":"Jemperli monotherapy could help eligible patients avoid chemotherapy, radiation and surgery","namedEntities":{"people":[{"name":"Chris Murphy","role":"CFO, AnaptysBio"}],"products":["Jemperli (dostarlimab)","Quimilza (imsidolimab)"],"companies":[{"name":"AnaptysBio, Inc.","ticker":"ANAB","relationship":"filer; Jemperli discoverer and royalty holder"},{"name":"GSK","relationship":"licensee; develops and commercializes Jemperli; received FDA approval"},{"name":"TESARO, Inc.","relationship":"licensee (GSK company); original Jemperli collaboration partner"},{"name":"Vanda Pharmaceuticals","relationship":"partner (Quimilza collaboration)"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"FDA approval of Jemperli in a new indication (MSI-H/dMMR locally advanced rectal cancer) directly benefits ANAB via royalties on Jemperli sales, though ANAB is the royalty holder, not the developer or seller -- GSK received the approval and books the sales."},"tickerRelevance":{"others":[],"primary":"ANAB"},"globalImportance":45,"audienceRelevance":30,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"mid-cap biotech","eventGravity":"fda-approval-new-indication (indirect for filer via royalties)","royaltyModel":"ANAB benefits through royalties, not direct sales","householdBrandBoost":null,"retailFavoriteBoost":null}},"event_type":"fda_approval","event_type_secondary":null,"sentiment":"bullish","material_impact_score":4,"narrative":"GSK received FDA approval for Jemperli (dostarlimab) as the first and only immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancer -- a new indication for the antibody discovered by AnaptysBio.\n\nAnaptysBio holds royalty rights to Jemperli, so each approval expands the product's addressable market and ANAB's future royalty stream, even though GSK books the sales.\n\nApproval came ahead of the February 2027 PDUFA date under Priority Review with Fast Track and Breakthrough Therapy designations, supported by AZUR-1 data showing 68% of evaluable patients achieving sustained clinical complete responses at 12 months with no disease recurrences after a median follow-up of more than two years.\n\nGSK will present full AZUR-1 interim data as a late-breaking abstract at ESMO 2026 in Madrid on October 25.","key_figures":{"drugName":"Jemperli (dostarlimab)","phaseOfTrial":"AZUR-1 pivotal trial (interim analysis)","customDimensions":{"pdufa_date":"February 2027 (approval ahead of PDUFA date)","ccr12_central_review":"47% (54/116)","serious_adverse_reactions":"20%","ccr12_investigator_assessed":"68% (98/144)","msi_h_rectal_cancer_prevalence":"5-10% of rectal cancers","no_evidence_of_cancer_1yr_plus":"76% (110/144)"}},"named_entities":{"people":[{"name":"Chris Murphy","role":"CFO, AnaptysBio"}],"products":["Jemperli (dostarlimab)","Quimilza (imsidolimab)"],"companies":[{"name":"AnaptysBio, Inc.","ticker":"ANAB","relationship":"filer; 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