# Dostarlimab

Source: https://onco.cc/drugs/dostarlimab/  
OnCo record `dostarlimab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Dostarlimab is a PD-1 blocker famous for making rectal cancer disappear without surgery in every patient with a mismatch-repair-deficient tumour.

## Summary

Dostarlimab is a humanised IgG4 antibody against PD-1 that releases exhausted tumour-reactive T cells, given at 500 mg every 3 weeks for four doses and then 1,000 mg every 6 weeks. It is approved in dMMR endometrial cancer with carboplatin and paclitaxel (RUBY, with an overall survival benefit), in all-comer primary advanced or recurrent endometrial cancer with chemotherapy (2024), and for dMMR solid tumours. Its fame comes from the MSK rectal cancer study (Cercek, NEJM 2022), in which every patient with dMMR rectal cancer achieved a clinical complete response, sustained in more than 40 patients by 2025, without surgery, chemotherapy or radiation. That result led to an organ-preservation paradigm, a Breakthrough Therapy designation in 2025 and the AZUR-1 registrational trial. The durability of organ preservation is the open question.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Brand: Jemperli
- Modality: Monoclonal antibody (anti-PD-1)
- Mechanism: Humanised IgG4 anti-PD-1.
- Approvals: US 2021: dMMR recurrent/advanced endometrial cancer; dMMR solid tumours; US 2024: Primary advanced/recurrent endometrial cancer with chemotherapy (all-comers)
- Dosing: IV infusion; 500 mg every 3 weeks for 4 doses, then 1,000 mg every 6 weeks; with carboplatin-paclitaxel in endometrial cancer

## Notes

- Pancreatic cancer: the Jemperli label (effective 2 September 2025) indicates dostarlimab as a single agent for mismatch repair deficient recurrent or advanced solid tumours that have progressed on prior treatment with no satisfactory alternative, an accelerated approval that applies to the roughly 1 percent of pancreatic cancers with mismatch repair deficiency; the EU indication (Jemperli, marketing authorisation 21 April 2021) is endometrial cancer only.

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Dostarlimab
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Dostarlimab
- Jemperli label (openFDA): dMMR solid tumour indication: https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22JEMPERLI%22
- EMA Jemperli product page: https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli

## Connected records

- biomarkers: [dMMR (mismatch repair deficiency by IHC)](https://onco.cc/biomarkers/dmmr-ihc/), [MSI-high (microsatellite instability by PCR or sequencing)](https://onco.cc/biomarkers/msi-high/)
- cancers: [Advanced or recurrent endometrial cancer](https://onco.cc/cancers/advanced-recurrent-endometrial-cancer/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Endometrial cancer](https://onco.cc/cancers/endometrial/), [Endometrial cancer with no specific molecular profile](https://onco.cc/cancers/endometrial-nsmp/), [Metastatic cancer (cancer that has spread)](https://onco.cc/cancers/metastatic-cancer/), [Mismatch repair deficient (MSI-high) pancreatic ductal adenocarcinoma](https://onco.cc/cancers/msi-high-pdac/), [Mismatch-repair deficient (MSI-high) colorectal cancer](https://onco.cc/cancers/msi-high-colorectal/), [Mismatch-repair-deficient endometrial cancer](https://onco.cc/cancers/endometrial-mmr-deficient/), [p53-abnormal endometrial cancer, including uterine serous carcinoma](https://onco.cc/cancers/endometrial-p53-abnormal/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [POLE-ultramutated endometrial cancer](https://onco.cc/cancers/endometrial-pole-ultramutated/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/), [Uterine carcinosarcoma](https://onco.cc/cancers/uterine-carcinosarcoma/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [MSI and mismatch-repair testing](https://onco.cc/technologies/msi-mmr-testing/)
- targets: [CD96](https://onco.cc/targets/cd96/), [Mismatch repair proteins (MLH1, MSH2, MSH6, PMS2)](https://onco.cc/targets/mmr/), [PD-1](https://onco.cc/targets/pd1/)
- companies: [GOG Foundation](https://onco.cc/companies/gog-foundation/), [GSK](https://onco.cc/companies/gsk/)
- trials: [A 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](https://onco.cc/trials/nct03602859/), [A 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](https://onco.cc/trials/nct06062420/), [A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer](https://onco.cc/trials/nct05565378/), [A 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)](https://onco.cc/trials/nct06472076/), [A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer](https://onco.cc/trials/nct06521567/), [A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC)](https://onco.cc/trials/nct07108270/), [A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer](https://onco.cc/trials/nct06317311/), [A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China](https://onco.cc/trials/nct06640049/), [A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma](https://onco.cc/trials/nct06256588/), [A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2)](https://onco.cc/trials/nct06796907/), [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](https://onco.cc/trials/nct06567782/), [A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients](https://onco.cc/trials/nct06879717/), [A Study of the Duration of Dostarlimab in Untreated Mismatch Repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H) Locally Advanced Rectal Cancer](https://onco.cc/trials/nct07740720/), [AZUR-1](https://onco.cc/trials/azur-1/), [Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI](https://onco.cc/trials/nct06333314/), [DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer](https://onco.cc/trials/nct06757244/), [GARNET](https://onco.cc/trials/garnet/), [Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer](https://onco.cc/trials/nct06830239/), [Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple](https://onco.cc/trials/nct04126200/), [PRODIGE 90 - (FFCD 2204) Neoadjuvant Dostarlimab with Short Course Radiotherapy in a Watch-and-wait Strategy for Microsatellite Unstable or Mismatch Repair-defi](https://onco.cc/trials/nct06762405/), [RUBY / ENGOT-EN6 / GOG-3031](https://onco.cc/trials/ruby/), [Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers](https://onco.cc/trials/nct05239546/), [Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer](https://onco.cc/trials/nct05855200/), [XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC)](https://onco.cc/trials/nct07381777/)
- key papers: [Cercek 2022: six months of dostarlimab alone made rectal cancer disappear in every patient with mismatch-repair deficiency](https://onco.cc/key-papers/paper-cercek-dostarlimab-rectal-nejm-2022/), [GARNET: dostarlimab in mismatch repair-deficient recurrent or advanced endometrial cancer](https://onco.cc/key-papers/paper-garnet-dostarlimab-oaknin-jama-oncol-2020/), [Le 2017: mismatch-repair deficiency predicts response to PD-1 blockade across twelve tumour types, leading to the first tissue-agnostic drug approval](https://onco.cc/key-papers/paper-le-mmr-deficiency-science-2017/), [Nonoperative management of mismatch repair-deficient tumors](https://onco.cc/key-papers/paper-cercek-nonoperative-management-mismatch-repair-deficient-tumours-nejm-2025/), [RUBY: dostarlimab with chemotherapy for advanced or recurrent endometrial cancer](https://onco.cc/key-papers/paper-ruby-nejm-2023/)
- pairings: [Chemotherapy + PD-1/PD-L1 blockade, first-line advanced endometrial cancer](https://onco.cc/pairings/chemo-io-first-line-endometrial/), [Neoadjuvant checkpoint inhibitor → surgery (or no surgery) in dMMR colorectal cancer](https://onco.cc/pairings/neoadjuvant-io-dmmr/)
- roadmaps: [Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation](https://onco.cc/roadmaps/colorectal-roadmap/)
- ideas: [A funded programme of organ-preservation trials to avoid radical surgery](https://onco.cc/ideas/idea-fund-organ-preservation-programme/), [Randomise organ preservation against surgery in mismatch repair-proficient rectal cancer, with bowel function as a co-primary endpoint](https://onco.cc/ideas/idea-crc-organ-preservation-randomised-in-pmmr-rectal/)
- institutions: [Memorial Sloan Kettering Cancer Center](https://onco.cc/institutions/mskcc/)
- terms: [Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)](https://onco.cc/terms/msi/)
- people: [Andrea Cercek](https://onco.cc/people/andrea-cercek/), [Luis A. Diaz Jr.](https://onco.cc/people/luis-diaz/), [Mansoor Raza Mirza](https://onco.cc/people/mansoor-raza-mirza/)
- pathways: [Endometrial cancer (KEGG map)](https://onco.cc/pathways/endometrial-cancer-signalling/), [Mismatch repair & microsatellite instability](https://onco.cc/pathways/mismatch-repair-msi/), [Mutagenesis & mutational signatures](https://onco.cc/pathways/mutagenesis-signatures/)
- drugs: [VENTANA MMR RxDx Panel](https://onco.cc/drugs/ventana-mmr-rxdx/)

---
JSON: https://onco.cc/api/v1/entities/dostarlimab.json