Drugs / Dostarlimab
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed solid adenocarcinoma with mucin production 1 milestone | |||||
| Filed | US (FDA) | — | solid adenocarcinoma with mucin production | — | “It is also under FDA review for the treatment of adult patients with dMMR recurrent or advanced solid tumours.” gsk.com ↗ |
| Filed stage I endometrioid carcinoma 3 milestones | |||||
| Filed | US (FDA) | Jemperli | stage I endometrioid carcinoma | 2024-04-24 | “FDA accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab)” gsk.com ↗ |
| Filed | US (FDA) | Jemperli | stage I endometrioid carcinoma | 2023-06-06 | “A second BLA submitted by GSK was accepted by the FDA during the first quarter of 2021 for JEMPERLI in pan-deficient mismatch repair tumors (PdMMRT).” anaptysbio.com ↗ “the US Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab)” gsk.com ↗ “In the first quarter of 2020, the FDA accepted the first Biologics License Application (BLA) filing for dostarlimab” anaptysbio.com ↗ |
| Filed | EU (EMA) | Jemperli | stage I endometrioid carcinoma | 2023-04-25 | “Marketing Authorisation Application for dostarlimab are currently under review by the US Food and Drug Administration and the European Medicines Agency” gsk.com ↗ “the EMA accepted GSK’s Marketing Authorization Application (MAA) for approval of dostarlimab in the EU for endometrial cancer” anaptysbio.com ↗ “EMA validated the Company’s Type II Variation for a potential new indication for Jemperli (dostarlimab)” gsk.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Jemperli | — | 2021-04-21 | europa.eu ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT06551142 | Sep 2024 → Oct 2028 expected | neoplasm | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 1 | NCT05980416 | Aug 2023 → May 2025 | gastric neoplasm | Elevation Oncology | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05819892 | Jul 2023 → Mar 2027 expected | endometrial cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05646082 | May 2023 → Jul 2026 overdue | Kaposi's sarcoma | Imperial College London | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04926324 | Jul 2022 → Nov 2024 | rectal cancer | University of Iowa | Terminated | No outcome recorded |
| Phase 1 | NCT05277051 | Mar 2022 → Aug 2027 expected | neoplasm | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04673448 | Oct 2021 → Dec 2025 overdue | fallopian tube carcinoma, female breast carcinoma, hereditary breast carcinoma, hereditary neoplastic syndrome +4 | University of Washington | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04544995 | Oct 2020 → Apr 2025 | neoplasm | GlaxoSmithKline | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04446351 | Jun 2020 → Dec 2026 expected | neoplasm | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03955978 | Oct 2019 → Mar 2024 overdue | endometrial cancer | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03307785 | Oct 2017 → Feb 2020 | metastatic malignant neoplasm, non-small cell lung carcinoma | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03250832 | Aug 2017 → Jun 2022 | neoplasm | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02723955 | Jun 2016 → Jul 2023 | neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02715284 | Mar 2016 → May 2026 overdue | neoplasm | Tesaro, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/212 trials | ||||||
| Phase 1/2 | NCT07860450 | Nov 2026 → Nov 2030 expected | endometrial carcinoma | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06405230 | Oct 2025 → Jul 2026 | non-small cell lung carcinoma | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 1/2 | NCT06879717 | Apr 2025 → Jan 2027 expected | non-small cell lung carcinoma | iOnctura | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06521567 | Mar 2025 → Oct 2026 expected | Hodgkins lymphoma, diffuse intrinsic pontine glioma, ependymoma, fibrolamellar hepatocellular carcinoma +5 | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06796907 | Mar 2025 → Jun 2027 expected | female reproductive system neoplasm | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06385548 | May 2024 | endometrial cancer | Vall d'Hebron Institute of Oncology | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05784012 | Nov 2023 → Mar 2027 expected | head and neck squamous cell carcinoma | Spanish Head And Neck Cancer Cooperative Group | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06065462 | Nov 2023 → Oct 2027 expected | ovarian clear cell cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05559879 | Aug 2023 → Apr 2027 expected | carcinoma, endometrial cancer | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05060432 | Sep 2021 → Jul 2024 | cancer of unknown primary site, head and neck cancer, lung neoplasm, melanoma | iTeos Therapeutics | Unknown | No outcome recorded |
| Phase 1/2 | NCT06655818 | Mar 2021 → Feb 2024 | refractory plasma cell neoplasm | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 1/2 | NCT04126200 | Oct 2019 → Apr 2025 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 258 trials · 4 met primary | ||||||
| Phase 2 | NCT07408063 | Apr 2026 → Jun 2030 expected | head and neck squamous cell carcinoma | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT07381777 | Jan 2026 → Jul 2028 expected | rectal cancer | Italian Oncology Group for Clinical Research | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07336147 | Dec 2025 → Dec 2027 expected | — | Chang Gung Memorial Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07224971 | Dec 2025 → May 2027 expected | non-small cell lung carcinoma | Liza Villaruz, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT07108270 | Nov 2025 → Mar 2030 expected | endometrial cancer | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 2 | NCT07013851 | Oct 2025 → Mar 2029 expected | reproductive system cancer | Spanish Ovarian Cancer Research Group | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07115927 | Sep 2025 → Apr 2030 expected | endometrial cancer | University College, London | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06830239 | Apr 2025 → Dec 2027 expected | malignant colon neoplasm | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 2 | NCT06567782 | Feb 2025 → Nov 2026 expected | colorectal cancer | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 2 | NCT06757244 | Feb 2025 → Feb 2028 expected | pancreatic neoplasm | Hopital Foch | Recruiting | No outcome recorded |
| Phase 2 | NCT06365970 | Jan 2025 → Jan 2027 | colorectal cancer | Ibrahim Halil Sahin | Withdrawn | No outcome recorded |
| Phase 2 | NCT06640049 | Oct 2024 → Oct 2027 expected | rectal cancer | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06278857 | Aug 2024 → Jun 2026 overdue | endometrial endometrioid adenocarcinoma, uterine carcinoma | Queensland Centre for Gynaecological Cancer | Recruiting | No outcome recorded |
| Phase 2 | NCT06333314 | Jul 2024 → Oct 2028 expected | adrenal cortex carcinoma, carcinoma of the ampulla of vater, duodenal adenocarcinoma, gastric adenocarcinoma +3 | UNICANCER | Recruiting | No outcome recorded |
| Phase 2 | NCT06317311 | May 2024 → Jul 2026 overdue | carcinoma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06238635 | Mar 2024 → Dec 2026 expected | cervical carcinoma | Meghan Shea | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04274023 | Jan 2024 | clear cell sarcoma | Italian Sarcoma Group | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06023862 | Jan 2024 → Aug 2027 expected | carcinoma, endometrium neoplasm, ovarian neoplasm, uterine cervix neoplasm +2 | Yonsei University | Recruiting | No outcome recorded |
| Phase 2 | NCT06059495 | Dec 2023 → Sep 2028 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | GERCOR - Multidisciplinary Oncology Cooperative Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06062420 | Nov 2023 → Sep 2026 overdue | head and neck carcinoma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05126342 | Nov 2023 → Nov 2024 | fallopian tube cancer, ovarian cancer, peritoneum cancer | AGO Research GmbH | Withdrawn | No outcome recorded |
| Phase 2 | NCT05870761 | Oct 2023 → Sep 2025 overdue | endometrial serous adenocarcinoma | Casey Cosgrove | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05855811 | Jul 2023 → Jul 2028 expected | secondary malignant neoplasm | Centre Leon Berard | Recruiting | No outcome recorded |
| Phase 2 | NCT05700721 | Jun 2023 → Dec 2029 expected | metastatic malignant neoplasm in the brain | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05723562 | Apr 2023 → Nov 2026 expected | rectal cancer | GlaxoSmithKline | Active not recruiting | Met primary |
| Phase 2 | NCT05239546 | Mar 2023 → Jun 2028 expected | colon carcinoma | University of Iowa | Recruiting | No outcome recorded |
| Phase 2 | NCT05405192 | Mar 2023 → Dec 2026 | gestational trophoblastic neoplasm | University of Miami | Withdrawn | No outcome recorded |
| Phase 2 | NCT05065021 | Feb 2023 → Jun 2025 | endometrioid adenocarcinoma, fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma +1 | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 2 | NCT05526989 | Dec 2022 → Nov 2026 expected | penile carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05565378 | Oct 2022 → Nov 2026 expected | non-small cell lung carcinoma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06926673 | Dec 2021 → May 2024 | neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT04983745 | Nov 2021 → Aug 2024 | neoplastic disease or syndrome | West Cancer Center | Unknown | No outcome recorded |
| Phase 2 | NCT04895046 | Oct 2021 → Sep 2022 | cholangiocarcinoma, metastatic malignant neoplasm | Walid Shaib, MD | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04837209 | Jul 2021 → Feb 2027 expected | triple-negative breast carcinoma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04779151 | Apr 2021 → Feb 2025 | biliary tract cancer, clear cell renal carcinoma, gastric adenocarcinoma, gastroesophageal adenocarcinoma +3 | Gustave Roussy, Cancer Campus, Grand Paris | Terminated | No outcome recorded |
| Phase 2 | NCT04774419 | Apr 2021 → Feb 2027 expected | endometrial cancer | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04681469 | Feb 2021 → Jun 2023 overdue | head and neck squamous cell carcinoma | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT04701307 | Feb 2021 → Apr 2027 expected | small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04584255 | Jan 2021 → Jul 2025 overdue | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, Her2-receptor negative breast cancer, PALB2-related cancer predisposition +1 | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04493060 | Dec 2020 → Dec 2023 | pancreatic ductal adenocarcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT04940637 | Dec 2020 → Jun 2024 | lung cancer, mesothelioma | University of Turin, Italy | Unknown | No outcome recorded |
| Phase 2 | NCT04581824 | Nov 2020 → Aug 2022 | non-small cell lung carcinoma | GlaxoSmithKline | Terminated | Met primary Stop: Business |
| Phase 2 | NCT04313504 | Nov 2020 → Jun 2025 | head and neck cancer | Trisha Wise-Draper | Completed | No outcome recorded |
| Phase 2 | NCT04409002 | Jul 2020 → Jan 2022 | malignant pancreatic neoplasm | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04139902 | Jun 2020 → Sep 2025 overdue | melanoma | Diwakar Davar | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04068753 | Feb 2020 → Dec 2026 expected | cervical carcinoma | University of Oklahoma | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03680508 | Dec 2019 → Mar 2026 overdue | adult hepatocellular carcinoma | University of Hawaii | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04165772 | Dec 2019 → Nov 2026 expected | rectum adenocarcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | Met primary |
| Phase 2 | NCT03955471 | Oct 2019 → Aug 2021 | ovarian neoplasm | Tesaro, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03833479 | Jun 2019 → Jul 2028 expected | cervical cancer | Spanish Ovarian Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03654833 | Jan 2019 → Oct 2023 | malignant mesothelioma | University of Leicester | Unknown | Met primary |
| Phase 2 | NCT03739710 | Jan 2019 → May 2024 | neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT05751629 | Nov 2018 → Apr 2022 | ovarian neoplasm | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03574779 | Nov 2018 → Jun 2024 | ovarian neoplasm | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03016338 | Nov 2017 → Jan 2021 overdue | endometrial cancer | University Health Network, Toronto | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03308942 | Sep 2017 → May 2020 | neoplasm | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03651206 | Jul 2020 → Jun 2027 expected | ovarian carcinosarcoma, uterine carcinosarcoma | ARCAGY/ GINECO GROUP | Recruiting | No outcome recorded |
| Phase 310 trials · 2 met primary | ||||||
| Phase 3 | NCT07867002 | Oct 2026 → Oct 2032 expected | endometrium adenocarcinoma | UNC Lineberger Comprehensive Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07684599 | Sep 2026 → Jul 2029 expected | endometrial cancer | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06762405 | Feb 2025 → Sep 2030 expected | rectum adenocarcinoma | Centre Hospitalier Universitaire Dijon | Recruiting | No outcome recorded |
| Phase 3 | NCT06472076 | Jun 2024 → Jun 2026 overdue | non-small cell lung carcinoma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06256588 | Mar 2024 → Jun 2028 expected | head and neck neoplasm | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT05855200 | Aug 2023 → Mar 2029 expected | colonic neoplasm | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT05201547 | Apr 2022 → Apr 2026 overdue | endometrial cancer | ARCAGY/ GINECO GROUP | Active not recruiting | Met primary |
| Phase 3 | NCT04679064 | Dec 2020 → Jan 2025 | ovarian cancer | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Unknown | No outcome recorded |
| Phase 3 | NCT03806049 | Dec 2019 → Dec 2022 | ovarian cancer | Nordic Society of Gynaecological Oncology - Clinical Trials Unit | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03602859 | Oct 2018 → Oct 2024 overdue | female reproductive organ cancer, ovarian neoplasm | Tesaro, Inc. | Active not recruiting | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07652515 | Aug 2026 → Aug 2030 expected | endometrial cancer | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06897527 | Jul 2025 → Jan 2027 expected | endometrial cancer | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT04387084 Background | Aug 2020 → Mar 2027 expected | skin cancer | University of Southern California | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03843359 Background | Mar 2019 → Apr 2024 overdue | neoplasm | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02817633 Background | Jul 2016 → Mar 2027 expected | neoplasm | Tesaro, Inc. | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT04655976 Background | Dec 2020 → Jun 2025 overdue | non-small cell lung carcinoma | GlaxoSmithKline | Active not recruiting | Missed primary |
| Phase 3 | NCT03981796 Comparator | Jul 2019 → Nov 2026 expected | neoplasm | Tesaro, Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 41
| Date | Issuer | Release |
|---|---|---|
| 2026-08-24 | GlaxoSmithKline | Regulatory Jemperli (dostarlimab) accepted for priority review by the US FDA for dMMR/MSI-H locally advanced rectal cancer gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) for patients with previously untreated stage II and III mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) locally advanced rectal cancer. |
| 2026-07-13 | GlaxoSmithKline | Results Jemperli (dostarlimab) achieves sustained clinical complete responses in dMMR/MSI-H locally advanced rectal cancer gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced positive interim results from the registrational phase II AZUR-1 trial of Jemperli (dostarlimab) in patients with stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer. |
| 2026-05-26 | GlaxoSmithKline | Results GSK to showcase long-term outcomes and pipeline expansion with latest oncology research at ASCO and EHA gsk.com ↗
Latest modelling data will predict the cure rate with dostarlimab plus chemotherapy in dMMR/MSI-H primary advanced or recurrent endometrial cancer, supporting patient care |
| 2025-01-20 | GlaxoSmithKline | Regulatory European Commission expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the European Commission has approved Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. |
| 2025-01-13 | ChemRar Research and Development Institute, LLC | Regulatory Дайджест FDA (статусы Breakthrough therapy designation) — декабрь 2024 года chemrar.ru ↗ |
| 2024-12-20 | GlaxoSmithKline | Results GSK announces FIRST trial met its primary endpoint of progression free survival in first line advanced ovarian cancer gsk.com ↗
The trial met its primary endpoint of PFS demonstrating a statistically significant difference with the addition of dostarlimab to both standard of care carboplatin-paclitaxel chemotherapy and niraparib maintenance, with or without bevacizumab. |
| 2024-12-16 | GlaxoSmithKline | Regulatory Jemperli (dostarlimab) receives US FDA Breakthrough Therapy Designation for locally advanced dMMR/MSI-H rectal cancer gsk.com ↗
GSK plc (LSE/NYSE: GSK) announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Jemperli (dostarlimab) for the treatment of patients with locally advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer. |
| 2024-12-16 | GlaxoSmithKline | Regulatory Jemperli (dostarlimab) plus chemotherapy receives positive CHMP opinion to expand approval to all adult patients with primary advanced or recurrent endometrial cancer gsk.com ↗ |
| 2024-08-01 | GlaxoSmithKline | Regulatory US FDA expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatment to show an overall survival benefit gsk.com ↗
This approval broadens the previous indication for Jemperli plus chemotherapy to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours who represent 70-75% of patients diagnosed with endometrial cancer and who have limited treatment options. |
| 2024-06-24 | GlaxoSmithKline | Regulatory Jemperli (dostarlimab) plus chemotherapy application accepted for review by the European Medicines Agency to expand use to all patients with primary advanced or recurrent endometrial cancer gsk.com ↗ |
| 2024-06-03 | GlaxoSmithKline | Results Jemperli (dostarlimab) trial continues to show unprecedented results with no evidence of disease in 100% of patients with locally advanced mismatch repair deficient (dMMR) rectal cancer gsk.com ↗
The trial showed an unprecedented 100% clinical complete response rate (cCR) in 42 patients who completed treatment with dostarlimab, defined as complete pathologic response or no evidence of tumours as assessed by magnetic resonance imaging, endoscopy and digital rectal exam. |
| 2024-04-24 | GlaxoSmithKline | Regulatory US FDA accepts for priority review GSK’s application for an expanded indication of Jemperli (dostarlimab) plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer gsk.com ↗
The FDA granted Priority Review for this application and assigned a Prescription Drug User Fee Act action date of 23 August 2024. |
| 2024-03-16 | GlaxoSmithKline | Results Positive RUBY phase III data show potential for Jemperli (dostarlimab) combinations in more patients with primary advanced or recurrent endometrial cancer gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced statistically significant and clinically meaningful overall survival (OS) results from Part 1 and progression-free survival (PFS) results from Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial in adult patients with primary advanced or recurrent endometrial cancer. |
| 2023-12-18 | GlaxoSmithKline | Results Jemperli (dostarlimab) plus Zejula (niraparib) combination significantly improved progression-free survival in primary advanced or recurrent endometrial cancer in RUBY Part 2 Phase III trial gsk.com ↗ |
| 2023-12-11 | GlaxoSmithKline | Regulatory GSK’s Jemperli (dostarlimab) plus chemotherapy approved as the first and only frontline immuno-oncology treatment in the European Union for dMMR/MSI-H primary advanced or recurrent endometrial cancer gsk.com ↗ |
| 2023-10-30 | GlaxoSmithKline | Results Phase III RUBY trial of Jemperli (dostarlimab) plus chemotherapy meets endpoint of overall survival in patients with primary advanced or recurrent endometrial cancer gsk.com ↗
The trial met its primary endpoint of overall survival (OS), demonstrating a statistically significant and clinically meaningful benefit in the overall patient population. |
| 2023-10-17 | GlaxoSmithKline | Results GSK highlights new data in non-small cell lung cancer and endometrial cancer at the European Society for Medical Oncology (ESMO) Congress 2023, reinforcing potential of Jemperli (dostarlimab) as a backbone immuno-oncology therapy gsk.com ↗
The results show PFS benefits are sustained beyond first progression and further support the OS benefits in patients treated with dostarlimab plus chemotherapy vs. chemotherapy alone despite the use of subsequent therapies. |
| 2023-10-16 | GlaxoSmithKline | Regulatory GSK receives positive CHMP opinion recommending approval of Jemperli (dostarlimab) plus chemotherapy as a new frontline treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Jemperli (dostarlimab) in combination with carboplatin-paclitaxel (chemotherapy), for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy. |
| 2023-07-31 | GlaxoSmithKline | Regulatory Jemperli (dostarlimab) plus chemotherapy approved in the US as the first new frontline treatment option in decades for dMMR/MSI-H primary advanced or recurrent endometrial cancer gsk.com ↗
The supplemental Biologics License Application (sBLA) supporting this new indication received Priority Review and was approved ahead of the Prescription Drug User Fee Act action date. |
| 2023-07-31 | AnaptysBio, Inc. | Regulatory AnaptysBio- and GSK-Partnered Immuno-Oncology Agent JEMPERLI (dostarlimab-gxly) plus Chemotherapy Approved in the U.S. for dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer anaptysbio.com ↗
The supplemental Biologics License Application (sBLA) supporting this new indication received Priority Review and was approved ahead of the Sept. 23, 2023 Prescription Drug User Fee Act action date. |
| 2023-06-06 | GlaxoSmithKline | Regulatory GSK receives US FDA file acceptance for Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. |
| 2023-04-25 | GlaxoSmithKline | Regulatory European Medicines Agency validates marketing authorisation application for Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) validated the Company’s Type II Variation for a potential new indication for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with a type of gynaecological cancer known as mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. |
| 2023-03-27 | GlaxoSmithKline | Results Phase III RUBY clinical trial demonstrates potential of Jemperli (dostarlimab) plus chemotherapy to redefine the treatment of primary advanced or recurrent endometrial cancer versus chemotherapy alone gsk.com ↗
A statistically significant and clinically meaningful improvement in progression free survival (PFS) was observed for dostarlimab plus carboplatin-paclitaxel in the mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) population (n=118) and in the overall population (n=494) versus placebo plus chemotherapy. |
| 2023-03-27 | AnaptysBio, Inc. | Results AnaptysBio- and GSK-partnered immuno-oncology agent Jemperli (dostarlimab-gxly) plus chemotherapy demonstrates statistically significant and clinically meaningful improvement in progression-free survival for the treatment of primary advanced or recurrent anaptysbio.com ↗
72% and 36% reduction in the risk of disease progression or death observed in the dMMR/MSI-H population and overall patient population, respectively |
| 2023-02-10 | GlaxoSmithKline | Regulatory US FDA grants regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer gsk.com ↗ |
| 2023-02-09 | GlaxoSmithKline | Regulatory US FDA Advisory Committee votes in support of trials designed to evaluate Jemperli (dostarlimab-gxly) as a potential treatment for mismatch repair-deficient/microsatellite instability-high locally advanced rectal cancer gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 8 to 5 in support of the question posed to the committee regarding whether data from two proposed single-arm trials will be “sufficient to characterize the benefits and risks” of Jemperli (dostarlimab-gxly) in the curative-intent setting for patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer. |
| 2022-12-07 | GlaxoSmithKline | Results PERLA phase II trial of Jemperli (dostarlimab) plus chemotherapy shows positive results in first-line metastatic non-squamous non-small cell lung cancer gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced results from the PERLA phase II clinical trial investigating dostarlimab in combination with chemotherapy versus pembrolizumab in combination with chemotherapy as a first-line treatment for patients with metastatic non-squamous non-small cell lung cancer (NSCLC). |
| 2022-12-02 | GlaxoSmithKline | Results Jemperli (dostarlimab) RUBY phase III trial met its primary endpoint in a planned interim analysis in patients with primary advanced or recurrent endometrial cancer gsk.com ↗
The trial met its primary endpoint of investigator-assessed progression-free survival (PFS). |
| 2022-12-02 | AnaptysBio, Inc. | Results AnaptysBio- and GSK-partnered immuno-oncology agent JEMPERLI (dostarlimab-gxly) meets primary endpoint in Phase 3 RUBY trial in primary advanced or recurrent endometrial cancer anaptysbio.com ↗
The JEMPERLI regimen showed a statistically significant and clinically meaningful benefit in the prespecified mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) patient subgroup and in the overall population. |
| 2022-10-05 | GlaxoSmithKline | Results GSK announces positive headline results from PERLA, the phase II trial of Jemperli (dostarlimab) plus chemotherapy in patients with metastatic non-squamous non-small cell lung cancer gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced positive headline results of the PERLA phase II trial, which met its primary endpoint of objective response rate (ORR) by Response Evaluation Criteria in Solid Tumours (RECIST) criteria as determined by blinded independent central review. |
| 2022-10-05 | AnaptysBio, Inc. | Results AnaptysBio and GSK-partnered immuno-oncology agents JEMPERLI (dostarlimab-gxly) and cobolimab show positive progress in two separate non-small cell lung cancer trials anaptysbio.com ↗
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced that GSK’s study PERLA, a head-to-head trial of JEMPERLI vs. Keytruda in patients with metastatic non-squamous non-small cell lung cancer, met its primary endpoint of objective response rate (ORR) of dostarlimab plus chemotherapy versus pembrolizumab plus chemotherapy as assessed by blinded independent central review per RECIST v1.1. |
| 2021-08-17 | GlaxoSmithKline | Regulatory GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours gsk.com ↗
This indication received accelerated approval based on tumour response rate and durability of response. |
| 2021-08-17 | AnaptysBio, Inc. | Regulatory FDA Grants Accelerated Approval of JEMPERLI (dostarlimab-gxly) for dMMR Recurrent or Advanced Solid Tumors anaptysbio.com ↗
JEMPERLI is the first AnaptysBio -generated antibody to obtain FDA approval, and this is the second indication for JEMPERLI to be approved by the FDA in 2021. |
| 2021-04-23 | GlaxoSmithKline | Regulatory European Commission approves GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer gsk.com ↗
The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe. |
| 2021-04-23 | AnaptysBio, Inc. | Regulatory European Commission Approves JEMPERLI (dostarlimab), the First Anti-PD-1 Therapy Approved for Recurrent or Advanced dMMR/MSI-H Endometrial Cancer in Europe anaptysbio.com ↗
The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe . |
| 2021-04-22 | GlaxoSmithKline | Regulatory FDA grants accelerated approval for GSK’s JEMPERLI (dostarlimab-gxly) for women with recurrent or advanced dMMR endometrial cancer gsk.com ↗
GlaxoSmithKline plc today announced that the US Food and Drug Administration (FDA) has approved JEMPERLI (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company’s Biologics License Application. |
| 2021-04-22 | AnaptysBio, Inc. | Regulatory FDA Approves JEMPERLI (dostarlimab-gxly) for dMMR Endometrial Cancer anaptysbio.com ↗
JEMPERLI is the first AnaptysBio -generated antibody to obtain FDA approval. |
| 2021-02-26 | GlaxoSmithKline | Regulatory GSK receives CHMP positive opinion recommending approval of dostarlimab for women with recurrent or advanced endometrial cancer gsk.com ↗
This positive CHMP opinion brings us one step closer to providing dostarlimab as a new treatment option to women with endometrial cancer in Europe with the hope of improving outcomes. |
| 2021-01-16 | GlaxoSmithKline | Results GSK presents positive efficacy data of dostarlimab in mismatch repair-deficient (dMMR) solid cancers at ASCO Gastrointestinal Cancers Symposium gsk.com ↗
Study results (abstract #9) showed a 38.7% objective response rate (ORR) (N=106, 95% CI; 29.4–48.6) in patients with dMMR advanced solid cancers who received dostarlimab, an investigational anti-programmed death-1 (PD-1) monoclonal antibody. |
| 2020-04-23 | GlaxoSmithKline | Results GSK presents new data from the GARNET study demonstrating potential of dostarlimab to treat a subset of women with recurrent or advanced endometrial cancer gsk.com ↗
Treatment with dostarlimab showed an ORR of 42% (95% CI; 31-55) and a disease control rate of 58% (95% CI; 45-69). |
| 2019-03-19 | GlaxoSmithKline | Results Data from GARNET study indicates robust activity of dostarlimab in patients with advanced or recurrent endometrial cancer gsk.com ↗
The preliminary results demonstrate clinically meaningful and durable response rates of dostarlimab (anti-PD-1 antibody, formerly TSR-042), in this patient population, regardless of microsatellite instability status. |
All press releases naming this drug 43 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 105 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dostarlimab | “This is an open-label, single-arm, Phase 2 study which will evaluate the efficacy and safety of niraparib and dostarlimab (TSR-042) combination in patients with metastatic,...” NCT04983745 ↗93“Standard of Care Drugs (at investigator's discretion) may include: pembrolizumab, nivolumab, cemiplimab, durvalumab, dostarlimab, avelumab, and atezolizumab, or other immune...” NCT07224971 ↗ “ATOMICC trial: a randomized, open-label, phase II trial of anti-PD1, dostarlimab, as maintenance therapy for patients with high-risk locally advanced cervical cancer after...” PMID 35444013 ↗ Sep 2022 “maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab)” NCT07867002 ↗ “TSR-042 (dostarlimab, PD-1 binding antibody)” NCT03680508 ↗ “Dostarlimab 500 mg iv: day -49 and day -28” NCT04681469 ↗ “Dostarlimab” NCT04817956 ↗ |
| Known as | Dostarlimab gxly | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298124 ↗ |
| Known as | GSK-4057190 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298124 ↗ |
| Known as | Jemperli | “Patients received a trial treatment called dostarlimab (also known by the brand name Jemperli).” PMID 34427115 ↗ Aug 2021 |
| Known as | TSR-042 | “This is an open-label, single-arm, Phase 2 study which will evaluate the efficacy and safety of niraparib and dostarlimab (TSR-042) combination in patients with metastatic,...” NCT04983745 ↗19“We propose a window of opportunity trial to evaluate safety and efficacy of a short course of the study combination, composed by an Anti-PD-1 monoclonal antibody (Dostarlimab...” NCT04681469 ↗ “This study will make it possible to evaluate the efficacy and safety of use of the combination of two products: niraparib and Dostarlimab (also called TSR-042).” NCT04779151 ↗ “TSR-042 (Dostarlimab) is a humanized mAb of the IgG4/kappa isotype that binds with high affinity to PD-1, resulting in inhibition of binding to PD-L1 and PD-L2.” NCT03308942 ↗ “Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer” NCT03955471 ↗ “Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes, on Cycle 1 Day 1, and then again on Cycle 2 Day 1.” NCT04139902 ↗ “Dostarlimab (TSR-042) is an investigational anti-PD-1 antibody that binds with high affinity to the PD-1 receptor.” PMID 33001143 ↗ Nov 2020 “Dostarlimab (previously referred to as TSR-042) is an IgG4 antibody.” NCT03250832 ↗ “Niraparib + TSR-042 (Dostarlimab)” NCT03651206 ↗ “Dostarlimab (TSR-042), 500 mg, IV” NCT01042379 ↗ “Dostarlimab (TSR-042)” NCT03602859 ↗ |
| Known as | WBP-285 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298124 ↗ |
| Action | Inhibit | “binds with high affinity to PD-1 resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2)” NCT02715284 ↗ |
| Modality | Monoclonal antibody | “Dostarlimab (160 mg, 20 mg/mL; or 500 mg, 50 mg/mL) is a humanized monoclonal antibody” NCT02715284 ↗ |
| Route | Intravenous | “Dostarlimab (TSR-042), 500 mg, IV” NCT01042379 ↗ |
| Target | PDCD1 | “Immunoglobulin G4, Anti-programmed Cell Death Protein 1 (PDCD1) (Humanized Clone ABT1 Gamma4-chain), Disulfide with Humanized Clone ABT1 Kappa-chain, Dimer” NCT04701307 ↗ |