Last update 24 Jun 2024

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
+ [9]
Target
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Drug Highest PhaseApproved
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Priority Review (AU)
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Recurrent Endometrial Cancer
EU
12 Jan 2024
Recurrent Endometrial Cancer
IS
12 Jan 2024
Recurrent Endometrial Cancer
LI
12 Jan 2024
Recurrent Endometrial Cancer
NO
12 Jan 2024
Advanced Endometrial Carcinoma
EU
12 Dec 2023
Advanced Endometrial Carcinoma
IS
12 Dec 2023
Advanced Endometrial Carcinoma
LI
12 Dec 2023
Advanced Endometrial Carcinoma
NO
12 Dec 2023
Mismatch repair-deficient Solid Tumors
US
17 Aug 2021
Microsatellite instability-high Endometrial Carcinoma
EU
21 Apr 2021
Microsatellite instability-high Endometrial Carcinoma
IS
21 Apr 2021
Microsatellite instability-high Endometrial Carcinoma
LI
21 Apr 2021
Microsatellite instability-high Endometrial Carcinoma
NO
21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma
EU
21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma
IS
21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma
LI
21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma
NO
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
JP
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
AR
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
BE
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
BR
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
BG
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
CA
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
HR
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
CZ
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
EE
10 Jun 2024
PD-L1 positive Non-Small Cell Lung CancerPhase 3
FI
10 Jun 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
41
jdpblzgirv(mddmuyusxf) = concfxdsvj ramluzouxe (llmqzfktfq )
Met
Positive
02 Jun 2024
Not Applicable
-
vjmxblqswe(reqmogrzse) = acceptable safety profile in line with the TIGIT:PD-1 class ibuqcdtbwi (sjdayjrnon )
Positive
10 May 2024
Phase 3
Endometrial Carcinoma
Microsatellite Stable (MSS) | Proficient DNA Mismatch Repair (pMMR) | MSI-High | ...
-
bywqsfgkod(wijkhgbhzl) = vxmrsggswq pjjwgsujwl (cxyiblalrs, 32.6–NR)
Met
Positive
16 Mar 2024
bywqsfgkod(wijkhgbhzl) = cqvphbcwwx pjjwgsujwl (cxyiblalrs, 22.1–35.6)
Met
Phase 3
Endometrial Carcinoma
First line
Proficient DNA Mismatch Repair (pMMR)
-
pmrhrcjsmg(eqexhewcvm) = igrmimutum kudtqtogcf (ejqgmkxnct )
Met
Positive
16 Mar 2024
Placebo+chemotherapy+placebo
pmrhrcjsmg(eqexhewcvm) = kzvqquxtzv kudtqtogcf (ejqgmkxnct )
Met
Phase 1
143
bodejnuwuv(dqmsquycmw) = axdbdelntu sbvhuaiqcl (mksxgbkpkm )
Positive
10 Mar 2024
Phase 3
-
Jemperli +Zejula
comfmwzxaq(hrlaxnqiml) = significantly improved progression-free survival (PFS) versus placebo cjoiomxbvo (lqwqibpczr )
Positive
18 Dec 2023
placebo
Phase 1
Mismatch repair-deficient Endometrial Carcinoma
Second line
Tertiary Lymphoid Structure
14
mmgpegzydt(yjpqaaxcxw) = wmkvpipwgc hjadxoqaex (voluxejgmw )
-
07 Dec 2023
Chemotherapy
mmgpegzydt(yjpqaaxcxw) = auwpknqrlg hjadxoqaex (voluxejgmw )
Phase 2
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
First line
PD-L1 status | EGFR | ALK ...
243
wmsdbigwre(crtxayjnra) = fbvjxbaiyc wjxuilyvsh (aejguxfcgc )
Positive
02 Dec 2023
Pembrolizumab + CT
wmsdbigwre(crtxayjnra) = lthswbmbyi wjxuilyvsh (aejguxfcgc )
Phase 1
Solid tumor
Second line
MSI-High | Deficient DNA Mismatch Repair (dMMR)
327
mcsfxhohjd(mudvrlmmpc) = tfjllmtzil puhzpuucvy (omcppraeme, 38.6 - 49.6)
Positive
24 Nov 2023
Phase 3
-
Dostarlimab+chemotherapy
grysbsqfnh(kniybbmqry) = The trial met its primary endpoint of overall survival, demonstrating a statistically significant and clinically meaningful benefit in the overall patient population. tuxwmjcbgq (bsyywftjnx )
Met
Positive
30 Oct 2023
Placebo+chemotherapy
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