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

Allison Singier1, Stéphane Vignot2, David Desplas3

  • 1EPI-PHARE, Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products, and French National Health Insurance), 143-147 Boulevard Anatole France, 93285, Saint-Denis Cedex, France. allison.singier@inserm.fr.

Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|March 3, 2026
PubMed
Abstract

Insights

This study found that real-world use of dostarlimab plus chemotherapy in advanced endometrial cancer patients showed less favorable survival outcomes compared to clinical trials. The safety profile, however, remained comparable, offering valuable insights for routine clinical practice.

Area of Science:

  • Oncology
  • Immunotherapy
  • Real-world evidence

Background:

  • Dostarlimab, a PD-1 inhibitor, is approved for mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) endometrial cancer.
  • The Phase III RUBY trial supported its use with chemotherapy, leading to expanded approvals.
  • Limited real-world data exist for dostarlimab plus chemotherapy in routine clinical practice.

Purpose of the Study:

  • To describe patient characteristics, survival, and safety outcomes.
  • To evaluate dostarlimab plus chemotherapy in a real-world setting for advanced or recurrent endometrial cancer.

Main Methods:

  • Utilized the French National Health Data System (SNDS) for patient data.
  • Included patients receiving dostarlimab via an early access program.
  • Estimated overall survival (OS), time to treatment discontinuation (TTD), and real-world progression-free survival (rwPFS) using Kaplan-Meier methods.

Main Results:

  • Included 644 patients with dMMR/MSI-H endometrial cancer, median age 71, mostly with metastatic disease.
  • Median OS not reached; 1-year OS probability was 72.8%.
  • Median TTD and rwPFS were 8.6 and 9.7 months, respectively. Hematologic and digestive adverse events were most frequent.

Conclusions:

  • This real-world cohort was older, more comorbid, and had more advanced disease than the RUBY trial population.
  • Survival outcomes were less favorable in this real-world setting.
  • The safety profile of dostarlimab plus chemotherapy was comparable to clinical trial data.

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