Last reviewed · How we verify
Dostarlimab (TSR-042)
Dostarlimab (TSR-042) is a PD-1 inhibitor Small molecule drug developed by Tesaro, Inc.. It is currently in Phase 3 development for Endometrial cancer, mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), Non-small cell lung cancer (in combination with chemotherapy), Gastric or gastroesophageal junction cancer.
Dostarlimab is a monoclonal antibody that blocks PD-1 on T cells, allowing the immune system to recognize and attack cancer cells.
Dostarlimab (TSR-042) is a programmed cell death protein 1 antagonist, classified as an antibody. It is being studied in clinical trials for various indications, including rectal adenocarcinoma and advanced adult primary liver cancer.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Dostarlimab (TSR-042) |
|---|---|
| Sponsor | Tesaro, Inc. |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Dostarlimab binds to programmed death receptor 1 (PD-1) on T cells, preventing interaction with its ligands (PD-L1 and PD-L2) on tumor cells and antigen-presenting cells. This blockade releases the 'brakes' on T-cell-mediated immunity, restoring anti-tumor immune responses. It is a humanized IgG4 monoclonal antibody designed to enhance durable anti-tumor immunity.
Approved indications
- Endometrial cancer, mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H)
- Non-small cell lung cancer (in combination with chemotherapy)
- Gastric or gastroesophageal junction cancer
Common side effects
- Fatigue
- Nausea
- Diarrhea
- Immune-mediated colitis
- Immune-mediated pneumonitis
- Immune-mediated hepatitis
Key clinical trials
- Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma (PHASE2)
- A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer (PHASE2)
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (PHASE2)
- Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery (PHASE2)
- Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer (PHASE3)
- Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors (PHASE2)
- Dostarlimab and Cobolimab in Advanced Cervical Cancer (PHASE2)
- Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dostarlimab (TSR-042) CI brief — competitive landscape report
- Dostarlimab (TSR-042) updates RSS · CI watch RSS
- Tesaro, Inc. portfolio CI
Frequently asked questions about Dostarlimab (TSR-042)
What is Dostarlimab (TSR-042)?
How does Dostarlimab (TSR-042) work?
What is Dostarlimab (TSR-042) used for?
Who makes Dostarlimab (TSR-042)?
What drug class is Dostarlimab (TSR-042) in?
What development phase is Dostarlimab (TSR-042) in?
What are the side effects of Dostarlimab (TSR-042)?
What does Dostarlimab (TSR-042) target?
Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Tesaro, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Endometrial cancer, mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H)
- Indication: Drugs for Non-small cell lung cancer (in combination with chemotherapy)
- Indication: Drugs for Gastric or gastroesophageal junction cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing