Last update 30 Jun 2025

Dostarlimab-gxly

Overview

Basic Info

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)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Priority Review (Australia)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Dostarlimab-gxly

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PD-L1 positive Non-Small Cell Lung CancerPhase 3
United States
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
China
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
Japan
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
Argentina
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
Belgium
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
Brazil
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
Bulgaria
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
Canada
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
Finland
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
France
10 Jun 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Recurrent Endometrial Cancer
dMMR/MSI-H | MMRp/MSS
494
Dostarlimab plus Carboplatin-Paclitaxel (DOST+CP)
mdzmbyxrbi(nvczlapvkd) = pewhbjuhrw zokpfqcunk (rxvwrsuhmx )
Positive
30 May 2025
Placebo plus Carboplatin-Paclitaxel (PBO+CP)
mdzmbyxrbi(nvczlapvkd) = owwokvdnij zokpfqcunk (rxvwrsuhmx )
Phase 2
117
modnpkovur(jbbkkjwdxv) = ilbfbvmcsc evgozfzkcn (aaokfnikbk )
Positive
27 Apr 2025
(dMMR, locally advanced rectal cancer)
ijjzvhdydw(jmppjgtbdl) = eskemxxjme bigrmfdghw (tsrucjqkrk )
Phase 1
67
(SerialCTRS)
nztgxuybps(xzjcekiacl): HR = 2.68 (95% CI, 1.09 - 6.59), P-Value = 0.03
Positive
27 Apr 2025
(RECIST 1.1)
Phase 2
-
Dostarlimab plus chemotherapy
idjvjlerwu(iqxvonipef) = wnzjjcvqye zjibeldyrd (glopxslgew, 14.5 - 27.3)
Positive
26 Mar 2025
Pembrolizumab plus chemotherapy
idjvjlerwu(iqxvonipef) = mbtjznwxhf zjibeldyrd (glopxslgew, 11.6 - 19.3)
Phase 1/2
4
Mafodotin+Dostarlimab+Belantamab
xjsgtdqjqo = ykonvhuege kvunqxleqa (rrnazxhity, fxjctrwbft - vggqaxjlby)
-
03 Mar 2025
Phase 1
-
Encelimab + Dostarlimab
wvcgizjfwv(swetyhjjsu) = ulhpzpzeom ninclviphu (mvjeoowneo )
Negative
27 Feb 2025
wvcgizjfwv(swetyhjjsu) = yzbimxskec ninclviphu (mvjeoowneo )
Phase 3
Ovarian Cancer
First line
-
SOC + Placebo
gjormzyvmx(iupvwvcosa) = 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. aszttbmuqh (vtpcgtrsfz )
Met
Positive
20 Dec 2024
SOC + niraparib
Phase 2
Mismatch repair-deficient Rectal Cancer
First line
MSI-High | Deficient DNA Mismatch Repair (dMMR)
42
povmoslekb(tgcbluaeix) = tkxgqzkmmn mlarpptuoh (beciodjufm )
Positive
16 Dec 2024
Not Applicable
29
ulbgcjebyc(nzjtyspbbo) = Serious AEs occurred in 4 (13.8%) pts; none were directly related to treatment ogmedzpagf (bbxswxmidy )
Positive
07 Dec 2024
Phase 2
243
yiqsvdptzm(ucjnurhqui) = xlamsknzlx ipuryptjqi (wezwrsjqzp, 14.5 - 27.3)
Positive
05 Nov 2024
yiqsvdptzm(ucjnurhqui) = xhabgwirsp ipuryptjqi (wezwrsjqzp, 11.6 - 19.3)
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Approval

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Biosimilar

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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