marked.bio

anti-PD-1 antibody · antibody

dostarlimab

20 active trials across 2 of our biomarkers, targeting PD-1. 6 active approvals for a biomarker on marked.bio.

Also known as TSR-042, Jemperli.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
dostarlimab
FDA, 2021
recurrent or advanced dMMR, progressed on or after platinum AA 22/04/2021, converted to regular approval 09/02/2023 (after platinum in any setting, not candidates for curative surgery or radiation). Source
EU (EMA), 2021
recurrent or advanced dMMR/MSI-H, progressed after platinum Conditional MA 21/04/2021, switched to standard MA 07/12/2023. Source
Jemperli 		MSI-H / dMMR endometrial Approved 2021 Approved 2021

In the US approval report

GARNET (dMMR endometrial cohort) single-arm, 141 patients
Response 45% (37-54)Lasting 86% of responses lasted 12 months or more

Serious side effects 38%Stopped for side effects 10%Fatal 0.7%

Trial details and side effects
Patients
dMMR endometrial cancer after platinum chemotherapy (NCT02715284)
Most common side effects
fatigue/asthenia 49%, anaemia 35%, nausea 32%, diarrhoea 29%, constipation 23%, vomiting 23% (150 patients)
Notes
US label rev. 09/2025.
Source
US approval report

In the EU product information

GARNET (dMMR endometrial cohort) single-arm, 143 patients
Response 45.5% (37-54)Lasting not reached; 80% of responses lasted 12 months or more

Trial details and side effects
Patients
dMMR endometrial cancer after platinum chemotherapy (NCT02715284)
Most common side effects
fatigue/asthenia 49%, anaemia 35%, nausea 32%, diarrhoea 29%, constipation 23%, vomiting 23% (150 patients)
Notes
EU SmPC section 5.1 (GARNET dMMR/MSI-H endometrial cohort); complete responses 16%. Side effects from the US label.
Source
EU product information
dostarlimab with carboplatin + paclitaxel
FDA, 2023
primary advanced or recurrent dMMR/MSI-H dMMR/MSI-H restricted approval 2023; on 01/08/2024 FDA broadened it to all primary advanced or recurrent EC (no longer biomarker-restricted). Kept because dMMR/MSI-H patients remain covered. Exact 2023 date not checked against its own FDA announcement. Source
EU (EMA), 2023
first line, primary advanced or recurrent dMMR/MSI-H EC, candidates for systemic therapy II/0023, EC decision 07/12/2023. Broadened to all primary advanced or recurrent EC by II/0032 (EC decision 15/01/2025), so the current EU wording is no longer biomarker-restricted. Kept because dMMR/MSI-H patients remain covered (same approach as FDA row A104). Source
Jemperli 		MSI-H / dMMR endometrial Approved 2023 Approved 2023

In the US approval report

RUBY (dMMR/MSI-H population) vs placebo + carboplatin + paclitaxel, 60 vs 62 patients
PFS 30.3 months vs 7.7 months, HR 0.29 (0.17-0.50)OS HR 0.34 (0.18-0.62)

Serious side effects 39%Stopped for side effects 19%Fatal 1.2%

Trial details and side effects
Patients
primary advanced or recurrent dMMR/MSI-H endometrial cancer (NCT03981796)
Most common side effects
peripheral neuropathy 64%, fatigue 56%, nausea 54%, alopecia 54%, rash 37%, arthralgia 37% (241 patients)
Notes
Dostarlimab with carboplatin and paclitaxel. US label rev. 09/2025.
Source
US approval report

In the EU product information

RUBY (dMMR/MSI-H population) vs placebo + carboplatin + paclitaxel, 53 vs 65 patients
PFS not reached vs 7.7 months, HR 0.28 (0.16-0.50)OS not reached vs 31.4 months, HR 0.32 (0.17-0.63)

Trial details and side effects
Patients
primary advanced or recurrent dMMR/MSI-H endometrial cancer (NCT03981796)
Most common side effects
peripheral neuropathy 64%, fatigue 56%, nausea 54%, alopecia 54%, rash 37%, arthralgia 37% (241 patients)
Notes
EU SmPC section 5.1 (RUBY dMMR/MSI-H population; OS not formally tested in this subgroup). Side effects from the US label.
Source
EU product information
dostarlimab
FDA, 2026
stage II/III locally advanced MSI-H or dMMR rectal cancer AA 19/10/2026 (AZUR-1); on FDA Ongoing accelerated approvals list. Source
Jemperli 		MSI-H / dMMR rectal Approved 2026 accelerated Not approved

AZUR-1 single-arm, 116 evaluable (154 treated)
Response 47% sustained clinical complete response at 12 months (27-56)

Trial details and side effects
Patients
stage II-III MSI-H or dMMR locally advanced rectal cancer, previously untreated (NCT05723562)
Notes
Accelerated approval (October 2026). The response measure is a clinical complete response sustained for 12 months, without surgery.
Source
US approval report
dostarlimab
FDA, 2021
recurrent or advanced dMMR, progressed after prior treatment, no satisfactory alternatives AA 17/08/2021; still on the current label (1.2) and the FDA Ongoing accelerated approvals list. Source
Jemperli 		MSI-H / dMMR solid tumours (tumour-agnostic) Approved 2021 accelerated Not approved

GARNET (dMMR solid tumours) single-arm, 209 patients
Response 42% (35-49)

Serious side effects 34%Stopped for side effects 9%

Trial details and side effects
Patients
dMMR recurrent or advanced solid tumours after prior treatment (NCT02715284)
Most common side effects
fatigue/asthenia 42%, anaemia 30%, diarrhoea 25%, nausea 22% (267 patients)
Notes
Accelerated approval. Colorectal subgroup ORR 36%. US label rev. 09/2025.
Source
US approval report

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
MSI-H / dMMR 17 19 Phase 4
BRCA1/2 mutation 3 5 Phase 2

Sponsors

Industry sponsors leading active biomarker-selected trials of dostarlimab.

  1. GSK 7

Trials

20 of 24 trials shown

  1. A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC)

    Not yet recruiting Phase 4 GSK Started 2025Primary completion 2027-01 NCT06897527

    dostarlimab FDA EU

    Documented case of dMMR/MSI-H recurrent or advanced EC that has progressed on or following prior treatment with platinu…

    MSI-H / dMMRNeoplasms, Endometrial

  2. A Study of the Duration of Dostarlimab in Untreated Mismatch Repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H) Locally Advanced Rectal Cancer

    Not yet recruiting Phase 3 GSK Started 2026Primary completion 2029-12 NCT07740720

    dostarlimab FDA EU

    …MR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of 1 or more proteins indicates dMMR

    MSI-H / dMMRNeoplasms, Rectal

  3. PRODIGE 90 - (FFCD 2204) Neoadjuvant Dostarlimab with Short Course Radiotherapy in a Watch-and-wait Strategy for Microsatellite Unstable or Mismatch Repair-deficient Locally Advanced Rectal Cancer Patients

    Recruiting Phase 3 Centre Hospitalier Universitaire Dijon Started 2025Primary completion 2030-09 NCT06762405

    dostarlimab FDA EUBiological study on circulating tumor DNA (optional for the patient)

    …al adenocarcinoma with Mismatch-repair Deficient (dMMR)/ microsatellite instability-high (MSI-H).

    MSI-H / dMMRRectal Adenocarcinoma with Mismatch-repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H)

  4. Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

    Recruiting Phase 3 GSK Started 2023Primary completion 2029-03 NCT05855200

    dostarlimab FDA EUCAPEOXFOLFOX

    Has a tumor demonstrating the presence of either dMMR status or MSI-H

    MSI-H / dMMRColonic Neoplasms, Neoplasms, Colon

  5. Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line

    Active, not recruiting Phase 3 ARCAGY/ GINECO GROUP Started 2022Primary completion 2026-04 NCT05201547

    carboplatinpaclitaxeldostarlimab FDA EU

    MMRd/MSI-H tumor (first diagnosed by routine local IHC performed either on primitive tumour tissue o…

    MSI-H / dMMREndometrial Cancer

  6. A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC)

    Recruiting Phase 2 GSK Started 2025Primary completion 2030-03 NCT07108270

    dostarlimab FDA EUcarboplatinpaclitaxel

    …molecular subtype of defective mismatch repair (dMMR) or microsatellite instability high (MSI-H) determined by the central reference laboratory before study intervention.

    MSI-H / dMMRNeoplasms, Endometrial

  7. pReOperative Dostarlimab and Novel Therapies in EndOmetrial Cancer

    Not yet recruiting Phase 2 University College, London Started 2025Primary completion 2030-04 NCT07115927

    dostarlimab FDA EU

    … protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR

    MSI-H / dMMREndometrial Cancer

  8. Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer

    Not yet recruiting Phase 2 Grupo Español de Investigación en Cáncer de Ovario Started 2025Primary completion 2029-03 NCT07013851

    dostarlimab FDA EU

    … Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer

    MSI-H / dMMRMMRd/MSI-H Stage II-III Endometrial Cancer

  9. Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI

    Recruiting Phase 2 UNICANCER Started 2024Primary completion 2028-10 NCT06333314

    dostarlimab FDA EUChemotherapy

    Histologically proven, dMMR/MSI-H solid tumors that are not colorectal or endometrial cancers and including one of the foll…

    MSI-H / dMMRPancreatic Adenocarcinoma, Ampulla of Vater Carcinoma, Adrenocortical Carcinoma, Neuroendocrine Carcinoma

  10. DEWI: Watch-and-Wait With Dostarlimab in Localized dMMR/MSI-H Gastric/GEJ Adenocarcinoma Phase II Study

    Recruiting Phase 2 GERCOR - Multidisciplinary Oncology Cooperative Group Started 2024Primary completion 2028-09 NCT06059495

    dostarlimab FDA EU

    Tumor status confirmed to be dMMR/MSI-H as follows:

    MSI-H / dMMRAdenocarcinoma - GEJ, Gastric Adenocarcinoma

  11. A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China

    Active, not recruiting Phase 2 GSK Started 2024Primary completion 2027-10 NCT06640049

    dostarlimab FDA EU

    Participant has a tumor which can be categorized as dMMR or MSI-H by central assessment

    MSI-H / dMMRNeoplasms, Rectal

  12. SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)

    Recruiting Phase 2 Queensland Centre for Gynaecological Cancer Started 2024Primary completion 2026-06 NCT06278857

    dostarlimab FDA EU

    i. histologically or cytologically proven Stage 1, FIGO grade 1 or 2, MMR deficient (Absence of at least one MMR protein (MLH1, PMS2, MSH2, MSH6) by immunohistochemistry.) e…

    MSI-H / dMMREndometrial Cancer Stage I, Mmr Deficiency, Endometrioid Endometrial Adenocarcinoma, Immune-related Adverse Event

  13. Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2023Primary completion 2029-12 NCT05700721

    niraparib FDA EUdostarlimab

    Advanced BRCA1/2m cancer 2.

    BRCA1/2 mutationBrain Metastases

  14. Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers

    Recruiting Phase 2 University of Iowa Started 2023Primary completion 2028-06 NCT05239546

    dostarlimab FDA EU

    Biopsy proven dMMR (by IHC), Stage II or III colon cancer per CT imaging correlation with AJCC 8th edition, …

    MSI-H / dMMRColon Cancer, dMMR Colorectal Cancer

  15. A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

    Active, not recruiting Phase 2 GSK Started 2023Primary completion 2026-11 NCT05723562

    dostarlimab FDA EU

    Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment

    MSI-H / dMMRNeoplasms, Rectal

  16. Niraparib + Dostarlimab In BRCA Mutated Breast Cancer

    Active, not recruiting Phase 2 Dana-Farber Cancer Institute Started 2021Primary completion 2025-07 NCT04584255

    niraparib FDA EUdostarlimab

    Participants must have documented germline mutation in BRCA1, BRCA2 or PALB2 that is deleterious or suspected to be deleterious (known or predicted t…

    BRCA1/2 mutationStage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Breast Cancer

  17. Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery

    Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2021Primary completion 2027-02 NCT04774419

    dostarlimab FDA EU

    …ion In Locally Advanced, Mismatch Repair Deficient/Microsatellite Instability-High (MMR-D/MSI-H) Endometrial Cancer

    MSI-H / dMMREndometrial Cancer

  18. Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors

    Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2019Primary completion 2026-11 NCT04165772

    dostarlimab FDA EUcapecitabinefluorouracil

    Tumor specimen that demonstrates mismatch repair deficiency by Immunohistochemistry or microsatellite instability as demonstrated by NGS or PCR.

    MSI-H / dMMRRectal Adenocarcinoma, Clinical Stage: Stage II (T3-4, N-), Stage III (Any T, N+), Solid Tumor

  19. Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer

    Active, not recruiting Phase 1 University of Washington Started 2021Primary completion 2025-12 NCT04673448

    dostarlimabniraparib FDA EU

    …n tube or primary peritoneal cancer that is unresectable or metastatic, with a pathogenic mutation in BRCA1 or BRCA2 (either germline or somatic) as confirmed by next generation gene sequencing su…

    BRCA1/2 mutationAnatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, BRCA-Associated Malignant Neoplasm, BRCA Hereditary Ovarian Carcinoma

  20. Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors

    Active, not recruiting Phase 1 GSK Started 2016Primary completion 2026-05 NCT02715284

    dostarlimab FDA EU

    …ib, ceritinib or experimental) 4) Cohort F - Participants with recurrent or advanced dMMR/MSI-H solid tumors except endometrial cancers and gastrointestinal cancers, who have received p…

    MSI-H / dMMRNeoplasms