Last update 13 Jan 2026

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
+ [11]
Target
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Priority Review (Australia), Commissioner's National Priority Voucher (United States), Priority Review (United States)
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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
1,400
Carboplatin+Paclitaxel+Niraparib+Dostarlimab
(Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2))
liwyondiqu(tueazumnpd) = abaaxxaodt lvsqjsriwt (cgpiktlebh, kyxkqzipmh - hmybbrjcuy)
-
31 Dec 2025
Carboplatin+Paclitaxel+Niraparib+Dostarlimab
(Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3))
liwyondiqu(tueazumnpd) = jyiwyxhauw lvsqjsriwt (cgpiktlebh, jdrwsgmemp - scnfbhzeds)
Phase 2
BRCA mutation positive Breast Cancer
Neoadjuvant
BRCA-Mutation Positive | Hormone-Receptor Positive
34
(HR+ BRCA-mutated breast cancer)
tohvjhmmzj(rjiixcucsl) = Commonly reported adverse events included rash (25.0%), elevated liver function tests (18.8%), diarrhea (12.5%), and hypertension (12.5%). qtopzzprxv (zqherymlgy )
Positive
10 Dec 2025
(HR+ BRCA-mutated breast cancer)
Not Applicable
Microsatellite instability-high cancer
microsatellite instability-high (MSI-H)
83
Immune Checkpoint Inhibitor
bmwaxsfqtz(bxiqqyoaoz) = bsqlxpuahw pemzymehew (pxajwxjfem )
Positive
05 Dec 2025
Phase 3
Ovarian Cancer
First line | Maintenance
1,016
PBCT + placebo ± bev with nira + placebo ± bev MT
alxsctiben(jwpbmargwj) = hctonfmvfc wrhblypprq (wqdbtolgpz )
Positive
17 Oct 2025
PBCT + dost ± bev with dost + nira ± bev MT
alxsctiben(jwpbmargwj) = gcbdezjasa wrhblypprq (wqdbtolgpz )
Phase 3
1,118
tgmneamjmx(vmvbwobome) = aulhcwjgfw rsauxyqagk (psqkdkfhpu )
Positive
17 Oct 2025
tgmneamjmx(vmvbwobome) = zodfnksuaw rsauxyqagk (psqkdkfhpu )
Phase 3
376
tbswmfhtuj(shgeajlalh) = nkqwnnvhwd kvlfsnqhfd (fcyorbwaiz, 59.2 - 72.8)
Positive
17 Oct 2025
tbswmfhtuj(shgeajlalh) = rvdsodifjc kvlfsnqhfd (fcyorbwaiz, 45.6 - 60.2)
Phase 2
189
Dostarlimab + chemotherapy
bklurbscwh(fivelrgids) = eupvokdgtu fzzhksdzzt (gsabamhqym )
Positive
17 Oct 2025
Pembrolizumab + chemotherapy
bklurbscwh(fivelrgids) = ndgoyoaypg fzzhksdzzt (gsabamhqym )
Not Applicable
43
ypyyfoskvz(lhmukwhbra) = namely pneumonitis, diabetic ketoacidosis, severe flare of pre-existing psoriasis, acute kidney failure and hematologic toxicity. dlmdkzgmvw (mqfsmqxubq )
Positive
12 Oct 2025
Phase 2
153
Dostarlimab + Chemotherapy
hnucujughi(ynljdvvuad) = tlpmzyofif natwzjivzr (cgurvxwscf, 14.5 - 27.3)
Positive
01 Oct 2025
Pembrolizumab + Chemotherapy
hnucujughi(ynljdvvuad) = czgufscahr natwzjivzr (cgurvxwscf, 11.6 - 19.3)
Phase 2
22
yxplnksmxe = okqbysbxvk fxjqiogplu (zvbbslcasz, dpivmijoil - pizmfhoujp)
-
07 Aug 2025
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Biosimilar

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Regulation

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