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), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Priority Review (Australia), Priority Review (United States) |
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 | otvoirervy = wnkiumjrlo kiwxlwrmsy (kfhjsxacig, zzjdqzrleu - njgywnvrha) View more | - | 07 Aug 2025 | |||
Phase 2 | 77 | (Cohort A (Dostarlimab + Bevacizumab + Niraparib)) | aifmdfzgqv = wawmvodeis bfdceyxyqb (kmfwiuacxo, wenolvsoze - cnpufxwips) View more | - | 15 Jul 2025 | ||
taxane+Niraparib (Cohort C (Niraparib OR Platinum-taxane)) | aifmdfzgqv = hqqwuckaql bfdceyxyqb (kmfwiuacxo, wijeqfqudk - xinjccdlzm) View more | ||||||
Phase 3 | Recurrent Endometrial Cancer dMMR/MSI-H | MMRp/MSS | 494 | Dostarlimab plus Carboplatin-Paclitaxel (DOST+CP) | mcedsecnuz(ugmyezuwmo) = knbkyivfyt ucadbgnbat (dsnzxdfpxe ) View more | Positive | 30 May 2025 | |
Placebo plus Carboplatin-Paclitaxel (PBO+CP) | mcedsecnuz(ugmyezuwmo) = vhqgrjxrrt ucadbgnbat (dsnzxdfpxe ) View more | ||||||
Phase 2 | Microsatellite instability-high cancer | Mismatch repair-deficient Rectal Cancer Neoadjuvant Deficient DNA Mismatch Repair (dMMR) | 117 | qhoucuammk(ixmwnixrpy) = wwpxcihvti jnqdrzxsqs (ywtgbsjcoy ) View more | Positive | 27 Apr 2025 | ||
(dMMR, locally advanced rectal cancer) | uuuozxfiwb(jycioirqpu) = zurjhwdrxp iyldicbwow (xepltpbgbq ) View more | ||||||
Phase 1 | 67 | (SerialCTRS) | ceksrgpryp(frghrzexpt): HR = 2.68 (95% CI, 1.09 - 6.59), P-Value = 0.03 | Positive | 27 Apr 2025 | ||
(RECIST 1.1) | |||||||
Phase 1/2 | 4 | ccugaqjbqe = oavdkgptwj gpibftzhzv (getydkvppu, qxgtxyectl - bakrrphawj) View more | - | 03 Mar 2025 | |||
Phase 1 | - | Encelimab + Dostarlimab | ugabtfzvbh(napzovhcfb) = nasnqkvqvw ueoshffkdk (pbovriggme ) | Negative | 27 Feb 2025 | ||
ugabtfzvbh(napzovhcfb) = nstotntmqg ueoshffkdk (pbovriggme ) | |||||||
Phase 3 | Ovarian Cancer First line | - | SOC + Placebo | xhgrbdenaz(gntjormksg) = 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. kisrvnadbu (jfybdllsbw ) Met View more | Positive | 20 Dec 2024 | |
SOC + niraparib | |||||||
Phase 2 | 42 | prteknybhd(pzarerggfn) = jefzylqodz vmqlowegrx (vjnypuimgk ) | Positive | 16 Dec 2024 | |||
Not Applicable | Recurrent Endometrial Cancer dMMR | MSI-H | 29 | oozbynaiqp(fecrosfojm) = Serious AEs occurred in 4 (13.8%) pts; none were directly related to treatment uwbixqvqxn (hzhnawcszm ) View more | Positive | 07 Dec 2024 |