Drug Type Monoclonal antibody |
Synonyms Dostarlimab, Immunoglobulin G4, anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 gamma4-chain), disulfide with humanized clone ABT1 kappa-chain, dimer, 多斯塔利单抗 + [10] |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (21 Apr 2021), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Priority Review (Australia) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Dostarlimab-gxly |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Advanced Endometrial Carcinoma | European Union | 12 Jan 2024 | |
| Advanced Endometrial Carcinoma | Iceland | 12 Jan 2024 | |
| Advanced Endometrial Carcinoma | Liechtenstein | 12 Jan 2024 | |
| Advanced Endometrial Carcinoma | Norway | 12 Jan 2024 | |
| Recurrent Endometrial Cancer | European Union | 12 Jan 2024 | |
| Recurrent Endometrial Cancer | Iceland | 12 Jan 2024 | |
| Recurrent Endometrial Cancer | Liechtenstein | 12 Jan 2024 | |
| Recurrent Endometrial Cancer | Norway | 12 Jan 2024 | |
| Mismatch repair-deficient Solid Tumors | United States | 17 Aug 2021 | |
| Microsatellite instability-high Endometrial Carcinoma | European Union | 21 Apr 2021 | |
| Microsatellite instability-high Endometrial Carcinoma | Iceland | 21 Apr 2021 | |
| Microsatellite instability-high Endometrial Carcinoma | Liechtenstein | 21 Apr 2021 | |
| Microsatellite instability-high Endometrial Carcinoma | Norway | 21 Apr 2021 | |
| Mismatch repair-deficient Endometrial Carcinoma | European Union | 21 Apr 2021 | |
| Mismatch repair-deficient Endometrial Carcinoma | Iceland | 21 Apr 2021 | |
| Mismatch repair-deficient Endometrial Carcinoma | Liechtenstein | 21 Apr 2021 | |
| Mismatch repair-deficient Endometrial Carcinoma | Norway | 21 Apr 2021 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | United States | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | China | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Japan | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Argentina | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Belgium | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Brazil | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Bulgaria | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Canada | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Finland | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | France | 10 Jun 2024 |
Phase 2 | 22 | wwovtuiuzp = vedqempplc jcnxhydyod (treknodxhb, hfssscbosn - bgczeqclsc) View more | - | 07 Aug 2025 | |||
Phase 2 | 77 | (Cohort A (Dostarlimab + Bevacizumab + Niraparib)) | ykprheroyg = vkbuqqqchy szzzgxazle (zqpfyhwopj, dlxemdjfbd - hulyliolfn) View more | - | 15 Jul 2025 | ||
taxane+Niraparib (Cohort C (Niraparib OR Platinum-taxane)) | ykprheroyg = gskwmhvshe szzzgxazle (zqpfyhwopj, mqcgizqtlx - skqrcukdke) View more | ||||||
Phase 3 | Recurrent Endometrial Cancer dMMR/MSI-H | MMRp/MSS | 494 | Dostarlimab plus Carboplatin-Paclitaxel (DOST+CP) | ywjtdihtpz(rljctbrfed) = kguqflylty hhqgoouxrr (aybxljlpah ) View more | Positive | 30 May 2025 | |
Placebo plus Carboplatin-Paclitaxel (PBO+CP) | ywjtdihtpz(rljctbrfed) = chxrrwgddz hhqgoouxrr (aybxljlpah ) View more | ||||||
Phase 2 | Ovarian Cancer BRCA | CCNE1 | CHEK2 | 43 | Niraparib 200-300mg/Bevacizumab 7.5mg/kg | fvjvxqcbbh(offkirshcg) = No G3-G4 immune related AE oeoyhuvsto (eefbkbvdvt ) | Positive | 30 May 2025 | |
Niraparib/Bevacizumab/Dostarlimab 500mg | |||||||
Phase 2 | - | qshpytgkja(phxqeyqdld) = demonstrate clinically meaningful improvements in the trial nomyqmfewa (tougmioipa ) Met View more | Negative | 13 May 2025 | |||
Phase 2 | - | ugnhksmqnd(cbmcelnwzq) = showed a trend below the meaningful threshold pmnoeikvuv (fkygkejuhn ) | Negative | 13 May 2025 | |||
Phase 2 | Microsatellite instability-high cancer | Mismatch repair-deficient Rectal Cancer Neoadjuvant Deficient DNA Mismatch Repair (dMMR) | 117 | kmnnatgobr(rlkoovjnmx) = wlxsmvzyzb ohqisawgkz (hjcufnfzgx ) View more | Positive | 27 Apr 2025 | ||
(dMMR, locally advanced rectal cancer) | pjfkoczacl(hknrksdpby) = fycjsewyks ltmbxkuoff (ejrudyeojk ) View more | ||||||
Phase 1 | 67 | (SerialCTRS) | izxhnajnpq(cmjailbyvl): HR = 2.68 (95% CI, 1.09 - 6.59), P-Value = 0.03 | Positive | 27 Apr 2025 | ||
(RECIST 1.1) | |||||||
Phase 1/2 | 4 | hmmjeliivi = kufnqfywys daulojlnxw (hzigikqeva, qcfybnvffl - jtcxyxpald) View more | - | 03 Mar 2025 | |||
Phase 1 | - | Encelimab + Dostarlimab | eemgfxrxfv(ngwbcwhkib) = gsjtvazabh nsgoxwcrnw (ylkgznlndn ) | Negative | 27 Feb 2025 | ||
eemgfxrxfv(ngwbcwhkib) = emelwbbvba nsgoxwcrnw (ylkgznlndn ) |






