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Dostarlimab

drug
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Also known as Dostarlimab gxlyDostarlimab-gxlyGSK-4057190GSK4057190JemperliTsr 042Tsr-042Tsr042WBP-285WBP285

Summary

Dostarlimab (CHEMBL4298124) is an approved antibody (ATC L01FF07) targeting PDCD1; indicated across 33 conditions including neoplasm and endometrium neoplasm; with CIViC clinical evidence for 3 variant-indication associations (e.g. MSI High in endometrial cancer).

At a glance

  • Status: Approved (max clinical phase 4)
  • Modality: Antibody
  • ATC class: L01FF07
  • Targets: 1 (PDCD1)
  • Indications: 33 conditions
  • Clinical trials: 93
  • Precision-oncology evidence (CIViC): 3 variant–indication associations

Identifiers

Drug identity and classification

FieldValue
ChEMBL IDCHEMBL4298124
NameDostarlimab
TypeAntibody
Max phase4
ATCL01FF07

Also known as: Dostarlimab, Dostarlimab gxly, Dostarlimab-gxly, GSK-4057190, GSK4057190, Jemperli, Tsr 042, Tsr-042, TSR-042, Tsr042, WBP-285, WBP285

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

GeneTargetActionpAffinityCancer dependencyUniProt
PDCD1programmed cell death 1 (CD279)Binding0%Q15116

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): PDCD1.

Top Reactome pathways

3 total, by targets touching each:

PathwayTargetsGenes
Co-inhibition by PD-11PDCD1
Potential therapeutics for SARS1PDCD1
PD-L1(CD274) glycosylation and translocation to plasma membrane1PDCD1

Dominant GO biological processes

GO termTargets
B cell apoptotic process1
adaptive immune response1
negative regulation of tolerance induction1
negative regulation of T cell mediated immune response to tumor cell1
negative regulation of B cell apoptotic process1
apoptotic process1
humoral immune response1
negative regulation of inflammatory response1
regulation of immune response1
negative regulation of immune response1
negative regulation of T cell receptor signaling pathway1
negative regulation of T cell activation1
positive regulation of T cell apoptotic process1
regulatory T cell apoptotic process1
immune system process1

Indications & clinical

Indications

33 indications (4 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

IndicationTrial phaseMONDOEFO
neoplasm4MONDO:0005070EFO:0000616
endometrium neoplasm4MONDO:0021251MONDO:0011962
ovarian neoplasm3MONDO:0021068EFO:0003893
head and neck cancer3MONDO:0005627EFO:0006859
ovarian cancer3MONDO:0008170MONDO:0008170
non-small cell lung carcinoma3MONDO:0005233EFO:0003060
colonic neoplasm3MONDO:0005401MONDO:0021063
head and neck neoplasm3MONDO:0005586EFO:0005950
cervical carcinoma2MONDO:0005131EFO:0001061
sarcoma2MONDO:0005089EFO:0000691
melanoma2MONDO:0005105EFO:0000756
rectal cancer2MONDO:0006519EFO:1000657
small cell lung carcinoma2MONDO:0008433EFO:0000702
exocrine pancreatic carcinoma2MONDO:0005192EFO:0002618
angiosarcoma2MONDO:0016982EFO:0003968
breast neoplasm2MONDO:0021100MONDO:0007254
hereditary breast ovarian cancer syndrome2MONDO:0003582Orphanet:145
mesothelioma2MONDO:0005065EFO:0000588
colorectal carcinoma2MONDO:0024331EFO:1001951
penile carcinoma2MONDO:0006360EFO:1000465
rectal neoplasm2MONDO:0002165MONDO:0002165
carcinoma2MONDO:0004993EFO:0000313
pancreatic ductal adenocarcinoma2MONDO:0005184MONDO:0005184
plasma cell myeloma1MONDO:0009693EFO:0001378
head and neck squamous cell carcinoma1MONDO:0010150EFO:0000181
clear cell adenocarcinoma1MONDO:0005004EFO:0000348

7 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 93.

Phase distribution

PhaseTrials
PHASE253
PHASE115
PHASE1/PHASE212
PHASE310
Not specified2
PHASE41

Top trials by phase / activity

NCTPhaseStatusTitle
NCT06897527PHASE4NOT_YET_RECRUITINGA Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC)
NCT03602859PHASE3ACTIVE_NOT_RECRUITINGA Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer
NCT03981796PHASE3ACTIVE_NOT_RECRUITINGA Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer
NCT04655976PHASE3ACTIVE_NOT_RECRUITINGEfficacy Comparison of 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
NCT05201547PHASE3ACTIVE_NOT_RECRUITINGEndometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
NCT05855200PHASE3RECRUITINGStudy of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
NCT06256588PHASE3RECRUITINGA Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
NCT06472076PHASE3ACTIVE_NOT_RECRUITINGA Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)
NCT06762405PHASE3RECRUITINGPRODIGE 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
NCT03806049PHASE3WITHDRAWNTrial Comparing Niraparib-bevacizumab-Dostarlimab and Niraparib-bevacizumab to Standard of Care in Recurrent Ovarian Cancer
NCT04679064PHASE3UNKNOWNTrial on NIraparib-TSR-042 (Dostarlimab) vs Physician’s Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment
NCT01042379PHASE2RECRUITINGI-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
NCT03680508PHASE2ACTIVE_NOT_RECRUITINGTSR-022 (Anti-TIM-3 Antibody) and TSR-042 (Anti-PD-1 Antibody) in Patients With Liver Cancer
NCT03833479PHASE2ACTIVE_NOT_RECRUITINGTSR-042 as Maintenance Therapy for Patients With High-risk Locally Advanced Cervical Cancer After Chemo-radiation
NCT04068753PHASE2ACTIVE_NOT_RECRUITINGNiraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer
NCT04126200PHASE1/PHASE2ACTIVE_NOT_RECRUITINGPlatform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
NCT04139902PHASE2ACTIVE_NOT_RECRUITINGNeoadjuvant PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Melanoma
NCT04584255PHASE2ACTIVE_NOT_RECRUITINGNiraparib + Dostarlimab In BRCA Mutated Breast Cancer
NCT04701307PHASE2ACTIVE_NOT_RECRUITINGNiraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas
NCT04774419PHASE2RECRUITINGRadiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery
NCT04837209PHASE2ACTIVE_NOT_RECRUITINGRadiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer
NCT05060432PHASE1/PHASE2ACTIVE_NOT_RECRUITINGStudy of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
NCT05239546PHASE2RECRUITINGSingle Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers
NCT05526989PHASE2RECRUITINGStudy of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma
NCT05559879PHASE1/PHASE2RECRUITINGCabozantinib and Dostarlimab in Recurrent Gynecologic Carcinosarcoma
NCT05565378PHASE2ACTIVE_NOT_RECRUITINGA Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer
NCT05700721PHASE2RECRUITINGPhase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)
NCT05723562PHASE2ACTIVE_NOT_RECRUITINGA Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
NCT05784012PHASE1/PHASE2RECRUITINGTwo-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma
NCT05855811PHASE2RECRUITINGPREventing Second Cancers With DOSTARlimab
NCT05870761PHASE2ACTIVE_NOT_RECRUITINGCombination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma
NCT06023862PHASE2RECRUITINGA Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
NCT06059495PHASE2RECRUITINGWatch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study
NCT06062420PHASE2ACTIVE_NOT_RECRUITINGA Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202
NCT06065462PHASE1/PHASE2RECRUITINGSafety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100
NCT06238635PHASE2ACTIVE_NOT_RECRUITINGDostarlimab and Cobolimab in Advanced Cervical Cancer
NCT06278857PHASE2RECRUITINGSATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)
NCT06317311PHASE2ACTIVE_NOT_RECRUITINGA Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer
NCT06333314PHASE2RECRUITINGDostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI
NCT06405230PHASE1/PHASE2RECRUITINGEvaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Organoid (PDOs)s and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC)

Clinical evidence (CIViC)

Variant × indication × effect (3 predictive associations from 3 curated evidence items):

VariantIndicationEffectTherapyLevelCIViC
MSI HighEndometrial CancerSensitivity/ResponseCarboplatin + Dostarlimab + PaclitaxelCIViC BEID12341
MSI HighEndometrial CancerSensitivity/ResponsePaclitaxel + Dostarlimab + CarboplatinCIViC BEID12343
MSI HighRectum CancerSensitivity/ResponseDostarlimabCIViC BEID12368

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.

4 molecules share ≥1 primary target. Top 4 by shared-target count:

MoleculeSourceStatusShared targets
PYRVINIUMChEMBLPhase 4 (approved)PDCD1
RIFABUTINChEMBLPhase 4 (approved)PDCD1
GefitinibPubChemApprovedPDCD1
PomalidomidePubChemApprovedPDCD1

About this page

Generated deterministically by Sugi Atlas from primary biomedical databases via BioBTree. Every record on this page traces to a primary source.

Generated
Atlas version
v1.1.2
BioBTree
v2.0.2

Sources 30

This page pulls from 30 datasets indexed by BioBTree:

chebichembl_activitychembl_moleculechembl_targetcivic_evidenceclingen_dosageclinical_trialsdepmapefoensemblentrezgogoparentgtopdbgtopdb_interactiongtopdb_ligandhgncmeshmondomsigdbpatent_compoundpharmgkbpharmgkb_guidelinepubchempubchem_activityreactomereactomeparentrefseqtranscriptuniprot