Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2026 Mar 3.
doi: 10.1007/s40259-026-00768-y. Online ahead of print.

Real-World Use of Dostarlimab Plus Chemotherapy in Advanced or Recurrent dMMR Endometrial Cancer: A Nationwide Cohort Study in France

Allison Singier  1 , Stéphane Vignot  2 , David Desplas  3 , Mahmoud Zureik  3 , Nadia Haddy  3
Affiliations

Real-World Use of Dostarlimab Plus Chemotherapy in Advanced or Recurrent dMMR Endometrial Cancer: A Nationwide Cohort Study in France

Allison Singier et al. BioDrugs. .

Abstract

Background: Dostarlimab, a PD-1 inhibitor, was initially approved in Europe in 2021 for advanced or recurrent mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) endometrial cancer. The phase III RUBY trial later demonstrated improved survival with dostarlimab plus chemotherapy, leading to EU approval in this indication in 2023. However, real-world data on the use of dostarlimab in routine clinical practice remain limited.

Objective: This study aimed to describe patients' characteristics, survival, and safety outcomes of dostarlimab plus chemotherapy in this population.

Patients and methods: We used the French National Health Data System (SNDS) to include all patients with uterine corpus cancer who received dostarlimab through the French early access program between 27 September 2023 and 30 June 2024, with follow-up until 30 November 2025. Overall survival (OS), time to treatment discontinuation (TTD), and real-world progression-free survival (rwPFS; i.e. subsequent treatment, palliative care, or death) were estimated using the Kaplan-Meier method. Safety outcomes were identified using hospitalization diagnoses and outpatient dispensing, and their prevalence was reported per 1000 person-months (PM).

Results: The cohort included 644 patients with dMMR/MSI-H endometrial cancer (median age 71 years), most with metastatic disease (73.3%). At baseline, 22.2% of patients were obese, 20.0% had cardiovascular disease, and 20.2% had diabetes. During follow-up (median [IQR]: 18.8 months [10.8-21.9]), 264 patients (41.0%) died. Median OS was not reached, and the 1-year OS probability was 72.8% (95% CI 69.5-76.3). TTD and rwPFS were lower, with median of 8.6 and 9.7 months, and 1-year survival probabilities of 35.7% (95% CI 32.2-39.6) and 44.4% (95% CI 40.7-48.4), respectively. Apart from unspecific potential immune-related adverse events (AEs; 193.6/1000 PM), hematologic AEs were the most frequent (23.8/1000 PM), mainly anemia (18.9/1000 PM), followed by digestive AEs (14.0/1000 PM).

Conclusions: This first real-world study of dostarlimab plus chemotherapy in advanced or recurrent endometrial cancer involved an older, more comorbid, and less selected population with more advanced disease than in RUBY. Survival outcomes were less favorable, but the safety profile was comparable.

PubMed Disclaimer

Conflict of interest statement

Declarations. Conflicts of Interest: Allison Singier, Stéphane Vignot, David Desplas, Mahmoud Zureik, and Nadia Haddy declare that they have no conflicts of interest that might be relevant to the contents of this manuscript. Ethics Approval and Consent to Participate: The study was conducted in compliance with the French regulations on access and processing of personal data from the SNDS. EPI-PHARE has permanent regulatory access to the data from the French National Health Data System (SNDS) via its constitutive bodies ANSM and CNAM, in application of the provisions of the French Decree No. 2016-1871 of 26 December 2016 relating to the processing of personal data called the “National Health Data System”, the French law articles Art. R. 1461-1316 and R. 1461-1417 from the French Public Health Code and the French Data Protection Authority (CNIL) decision CNIL-2016-316.18. In accordance with the permanent regulatory access granted to EPI-PHARE via ANSM and CNAM, this work did not require any specific opinion from the French Ethical and Scientific Committee for Research, Studies, and Evaluations health (CESREES) nor approval from the CNIL. All requests in the database were made by duly authorized people. The study was registered on the study register of EPI-PHARE concerning studies from SNDS data under the reference T-2025-05-586. No informed consent is required for studies based on the SNDS. Consent to Publish: Not applicable Data Availability: In accordance with data protection legislation and the French regulation, the authors are not allowed to release or make public the data from the SNDS. However, any person or structure, public or private, for-profit or nonprofit, is able to access SNDS data in order to carry out a study, research or an evaluation in the public interest, upon authorization from the French Data Protection Office (CNIL), via the French Health Data Hub ( https://www.health-data-hub.fr/ ). Code Availability: Not applicable Authors’ Contributions: AS: conceptualization, methodology, formal analysis, validation, visualization, writing—original draft, writing—review & editing; SV: conceptualization, validation, writing—review & editing; DD: conceptualization, data curation, validation, writing—review & editing; MZ: conceptualization, funding acquisition, methodology, supervision, validation, writing—review & editing; NH: conceptualization, methodology, supervision, validation, writing—review & editing.

References

    1. Ferlay J, Ervik M, Lam F, et al. Global Cancer Observatory: Cancer Today (version 1.1). Lyon, France 2024.
    1. Concin N, Matias-Guiu X, Vergote I, et al. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma. Int J Gynecol Cancer. 2021;31:12–39. https://doi.org/10.1136/ijgc-2020-002230 . - DOI - PubMed
    1. Bendifallah S, Ouldamer L, Lavoue V, et al. Patterns of recurrence and outcomes in surgically treated women with endometrial cancer according to ESMO-ESGO-ESTRO consensus conference risk groups: results from the FRANCOGYN study group. Gynecol Oncol. 2017;144:107–12. https://doi.org/10.1016/J.YGYNO.2016.10.025 . - DOI - PubMed
    1. André T, Berton D, Curigliano G, et al. Antitumor activity and safety of dostarlimab monotherapy in patients with mismatch repair deficient solid tumors: a nonrandomized controlled trial. JAMA Netw Open. 2023;6:e2341165. https://doi.org/10.1001/JAMANETWORKOPEN.2023.41165 . - DOI - PubMed - PMC
    1. Mirza MR, Chase DM, Slomovitz BM, et al. Dostarlimab for primary advanced or recurrent endometrial cancer. N Engl J Med. 2023;388:2145–58. https://doi.org/10.1056/nejmoa2216334 . - DOI - PubMed

LinkOut - more resources