Dostarlimab
Dostarlimab is a PD-1 blocker famous for making rectal cancer disappear without surgery in every patient with a mismatch-repair-deficient tumour.
Approved in dMMR endometrial cancer (RUBY, with chemotherapy; OS benefit) and dMMR solid tumours. The MSK rectal cancer study (Cercek, NEJM 2022; 100% clinical complete response sustained in >40 patients by 2025) led to an organ-preservation paradigm and the AZUR-1 registrational trial.
1.Antibody binds PD-1
- Route
- IV infusion
- Schedule
- 500 mg every 3 weeks for 4 doses, then 1,000 mg every 6 weeks; with carboplatin-paclitaxel in endometrial cancer
- Dose modifications
- Standard immune-mediated event algorithm
- Monitoring
- Thyroid, LFTs, creatinine
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments. Plans generally require documented dMMR/MSI-H status for the endometrial and tumour-agnostic uses.
- Assistance programmes
- Together with GSK Oncology
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Appraised for
- dMMR/MSI-H recurrent or advanced endometrial cancer after platinum
- Notes
- The first-line combination with carboplatin-paclitaxel (RUBY) was appraised separately in 2024; check NICE for the current position.
- Cancer Drugs Fund
- Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA779 · NHS England Cancer Drugs Fund list · SMC advice: dostarlimab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 22 Apr 2021ApprovalUS
Accelerated approval, dMMR recurrent/advanced endometrial cancer after platinum source
- 17 Aug 2021ApprovalUS
dMMR solid tumours (tumour-agnostic, accelerated) source
- 31 Jul 2023ApprovalUS
dMMR primary advanced/recurrent endometrial cancer with chemotherapy (RUBY) source
- 1 Aug 2024ApprovalUS
All-comer primary advanced/recurrent endometrial cancer with chemotherapy source
- Jun 2025DesignationUS
Breakthrough Therapy designation, dMMR locally advanced rectal cancer (organ preservation) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2021 | dMMR recurrent/advanced endometrial cancer; dMMR solid tumours |
| US | 2024 | Primary advanced/recurrent endometrial cancer with chemotherapy (all-comers) |
| Adverse event |
|---|
| Fatigue |
| Anaemia |
| Rash |
| Nausea |
| Diarrhoea |
| Hypothyroidism |
| Transaminase increase |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | — |
| United Kingdom | NICE: recommended with chemotherapy for dMMR/MSI-H advanced endometrial cancer (TA1068) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Women with newly diagnosed advanced or recurrent endometrial cancer should receive a PD-1 antibody (dostarlimab or pembrolizumab) with their chemotherapy, and mismatch repair testing is now essential because women with dMMR tumours gain a very large and durable benefit. The gain in mismatch-repair-proficient tumours is real but smaller, and molecular classification (POLE, p53, MMR) is increasingly used to decide who benefits most.
Cercek's dostarlimab study is the clearest demonstration that immunotherapy can replace surgery in a solid tumour: patients with dMMR rectal cancer can keep their rectum and avoid the permanent effects of pelvic radiotherapy and surgery. Non-operative management after PD-1 blockade is now in guidelines for this group, and MMR testing before treatment of rectal cancer is essential. The approach applies only to the 5-10% of rectal cancers that are dMMR.
Patients with rectal cancer whose tumour is mismatch-repair deficient (about 5-10% of rectal cancers) can now be offered immunotherapy alone with the realistic expectation of avoiding surgery, radiotherapy and a permanent stoma. This requires mismatch repair testing on the diagnostic biopsy, close endoscopic and MRI surveillance, and treatment in an experienced centre. It does not apply to the 90% of rectal cancers that are mismatch-repair proficient.
This paper established a new regulatory paradigm: a drug approved for a molecular feature regardless of organ. It made MSI/MMR testing standard across advanced cancers and remains the clearest example of a biomarker that works across histologies. It also anchored the idea that mutation load, via neoantigens, is what makes tumours visible to T cells.
Latest papers
topQuery for this drug: (TITLE:"Dostarlimab" OR ABSTRACT:"Dostarlimab" OR TITLE:"Jemperli" OR ABSTRACT:"Jemperli") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Dostarlimab, not a curated reading list.
Pages like this
not linked directly; found by shared links- Key paperLe 2015: PD-1 blockade works in tumours with mismatch-repair deficiency, whatever the organ
Shares Luis A. Diaz Jr., Cercek 2022: six months of dostarlimab alone made rectal cancer disappear in every patient with mismatch-repair deficiency, Le 2017: mismatch-repair deficiency predicts response to PD-1 blockade across twelve tumour types, leading to the first tissue-agnostic drug approval, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR).
- TrialNRG-GY018 / KEYNOTE-868
Shares Chemotherapy + PD-1/PD-L1 blockade, first-line advanced endometrial cancer, GOG Foundation, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Endometrial cancer.
- TrialKEYNOTE-177
Shares Le 2017: mismatch-repair deficiency predicts response to PD-1 blockade across twelve tumour types, leading to the first tissue-agnostic drug approval, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), PD-1, Immune checkpoint inhibitors.
- Key paperNICHE-2: a single dose of ipilimumab and two of nivolumab before surgery clears dMMR colon cancer in most patients
Shares Cercek 2022: six months of dostarlimab alone made rectal cancer disappear in every patient with mismatch-repair deficiency, Le 2017: mismatch-repair deficiency predicts response to PD-1 blockade across twelve tumour types, leading to the first tissue-agnostic drug approval, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), PD-1.
- TargetWRN helicase (MSI-high cancers)
Shares GSK, Mismatch repair & microsatellite instability, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Endometrial cancer.
- TrialCheckMate 8HW
Shares Le 2017: mismatch-repair deficiency predicts response to PD-1 blockade across twelve tumour types, leading to the first tissue-agnostic drug approval, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), PD-1, Colorectal cancer.
- TermClinical complete response (cCR)
Shares AZUR-1, Neoadjuvant checkpoint inhibitor → surgery (or no surgery) in dMMR colorectal cancer, Colorectal cancer.
- Key paperKEYNOTE-177: pembrolizumab instead of chemotherapy as first treatment for mismatch-repair-deficient metastatic colorectal cancer
Shares Luis A. Diaz Jr., Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), PD-1, Immune checkpoint inhibitors.