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Drug

Dostarlimab

Approved · EMA
ClassProgrammed cell death protein 1 antagonistEmerging researchLate-stage development

Also known as Jemperli, Immunoglobulin G4, anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 gamma4-chain), disulfide with humanized clone ABT1 kappa-chain, dimer.

RxNorm2539967ChEMBLCHEMBL4298124ATCL01FF07UNIIP0GVQ9A4S5
3
Research papers
55
Active clinical trials
Programmed cell death protein 1
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2, Multicenter, Open-label, Single Arm Study of Dostarlimab Plus Carboplatin-paclitaxel Followed by Dostarlimab Monotherapy in Japanese Patients With Primary Advanced or Recurrent Endometrial Cancer (RUBY-J)

Clinical trial2026-07-15Primary completion · ClinicalTrials.gov

Adjuvant Checkpoint Blockade Plus Radiation In Locally Advanced, Mismatch Repair Deficient/Microsatellite Instability-High (MMR-D/MSI-H) Endometrial Cancer

Clinical trial2026-07-09Results expected Q1 2027 · ClinicalTrials.gov

A Phase 1/2 Randomized Multi-Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan in Combination With Anti-Cancer Agents in Participants With Advanced Solid Tumors

Clinical trial2026-07-07Results expected Q2 2027 · ClinicalTrials.gov

A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate GSK5733584 in Combination With Immune Checkpoint Inhibition for Maintenance Treatment of Participants With Mismatch Repair Proficient (MMRp) Endometrial Cancer

Clinical trial2026-07-06Results expected Q3 2029 · ClinicalTrials.gov

A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)

Clinical trial2026-07-01Results posted · ClinicalTrials.gov

A Randomized, Multicenter, Double-blind, Phase 3 Study to Investigate the Safety and Efficacy of Belrestotug in Combination With Dostarlimab Compared With Placebo in Combination With Pembrolizumab in Participants With Previously Untreated, Unresectable, Locally Advanced or Metastatic PD-L1 Selected Non-small Cell Lung Cancer (GALAXIES Lung-301)

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors

Clinical trial2026-06-25Results expected Q3 2027 · ClinicalTrials.gov

A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

Clinical trial2026-06-24Results expected Q3 2026 · ClinicalTrials.gov

Antitumor Activity and Safety of Dostarlimab Monotherapy in Patients With Mismatch Repair Deficient Solid Tumors: A Nonrandomized Controlled Trial.

Research2023-11-01JAMA network open

Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer.

Research2023-03-27The New England journal of medicine

Approval: Jemperli (EMA)

Regulatory2021-04-21EMA

Clinical Activity and Safety of the Anti-Programmed Death 1 Monoclonal Antibody Dostarlimab for Patients With Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer: A Nonrandomized Phase 1 Clinical Trial.

Research2020-11-01JAMA oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Dostarlimab
Aliases & brands
JemperliImmunoglobulin G4, anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 gamma4-chain), disulfide with humanized clone ABT1 kappa-chain, dimer
RxNorm CUI
2539967
ChEMBL ID
CHEMBL4298124
ATC codes
L01FF07
UNII
P0GVQ9A4S5
Primary mechanism
Programmed cell death protein 1 antagonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Programmed cell death protein 1
PDCD1 · Q15116
ANTAGONISTProgrammed cell death protein 1 antagonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2021-04-21
Latest approval
2021-04-21
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2021-04-21Approval
Approval: Jemperli (EMA)
Indication: Jemperli is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and… Show full indication

Jemperli is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. Jemperli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability‑high (MSI‑H) recurrent or advanced EC that has progressed on or following prior treatment with a platinum‑containing regimen.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

78 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
78
registered trials across all phases
LATEST COMPLETION 2026
55
Active studies
28
Recruiting
12
Late-stage (III+)
8
Completed
15
Discontinued
PHASE DISTRIBUTIONn = 78
Phase 113Phase 1 / 210Phase 243Phase 2 / 31Phase 39Phase 42

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Phase 4, Open Label, Single-arm, Interventional, Multicenter Study to Evaluate the Safety of Dostarlimab in Adult Patients in India With Primary Advanced or Recurrent Endometrial Cancer

Not yet recruitingPH IVGlaxoSmithKlinen=1002030

Phase 4, Open Label, Non-comparative, Interventional, Multicenter Study to Evaluate the Safety of Dostarlimab in Adult Patients in India With Mismatch Repair Deficient (dMMR)/Microsatellite Instability-high (MSI-H) Recurrent or Advanced Endometrial Cancer (EC) That Has Progressed on or Following Prior Treatment With a Platinum-containing Regimen

Not yet recruitingPH IVGlaxoSmithKlinen=1002027

A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate GSK5733584 in Combination With Immune Checkpoint Inhibition for Maintenance Treatment of Participants With Mismatch Repair Proficient (MMRp) Endometrial Cancer

Not yet recruitingPH IIIGlaxoSmithKlinen=6102031

A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

RecruitingPH IIIGlaxoSmithKlinen=8922031

PRODIGE 90 - (FFCD 2204) - PREDIR-NEOREC Neoadjuvant Dostarlimab with Short Course Radiotherapy in a Watch-and-wait Strategy for Microsatellite Unstable or Mismatch Repair-deficient Locally Advanced Rectal Cancer Patients: a Randomized Phase II Trial Phase II Randomized Study Non-comparative - Multicenter

RecruitingPH IIICentre Hospitalier Universitaire Dijonn=682030

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Open-label, Phase II Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients

CompletedPH IITrisha Wise-Drapern=102026

Phase II Study of Niraparib and TSR-042 in Patients With Germline or Somatic BRCA1/2 and PALB2-Related Pancreatic Cancer

CompletedPH IIMayo Clinicn=222025

A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants

CompletedPH IIGlaxoSmithKlinen=1752024

A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants

CompletedPH IIGlaxoSmithKlinen=622024

A Phase I Open Label Study of GSK3359609 Administered Alone and in Combination With Anticancer Agents in Subjects With Selected Advanced Solid Tumors

CompletedPH IGlaxoSmithKlinen=8292023

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-033, an Anti-LAG-3 Monoclonal Antibody, Alone and in Combination With an Anti-PD-1 in Patients With Advanced Solid Tumors

CompletedPH ITesaro, Inc.n=1112023

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20202023
Major research themes5
Endometrial Neoplasms3DNA Mismatch Repair2Antibodies, Monoclonal, Humanized1Antineoplastic Combined Chemotherapy Protocols1Neoplasm Recurrence, Local1
Journals, researchers & institutions
Top journals
  • JAMA network open1
  • JAMA oncology1
  • The New England journal of medicine1
Leading researchers
  • Gilbert L3
  • Abdeddaim C2
  • Banerjee S2
  • Brown J2
  • Gravina A2
  • Moreno V2
  • Oaknin A2
  • Sabatier R2
Leading institutions
free-text, unnormalised
  • Centre de Lutte Contre le Cancer-Centre Oscar Lambret2
  • Hospital Fundación Jiménez Díaz2
  • Institut Paoli-Calmettes2
  • Levine Cancer Institute2
  • McGill University Health Centre2
  • Catalan Institute of Oncology1

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Carboplatin

Studied across 3 of the same disease areas as Dostarlimab in the shared literature.

3 shared diseases1 shared paper
Paclitaxel

Studied across 3 of the same disease areas as Dostarlimab in the shared literature.

3 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.