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

Sep 22, 2026

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Dostarlimab, a PD-1 inhibitor, received European approval in 2021 for advanced or recurrent dMMR/MSI-H endometrial cancer, later supported by the RUBY phase III trial showing improved survival when combined with chemotherapy. Real-world evidence in routine care remains limited. This nationwide French cohort study used SNDS data to characterize patient features, survival, and safety for patients receiving dostarlimab plus chemotherapy via the early access program.

LanguageEnglish

CategoryHealthcare

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Pages11

Reading Time28 min

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Abstract

Background

Objective

Patients and Methods

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BioDrugs (2026) 40:349–359 [https://doi.org/10.1007/s40259-026-00768-y](https://doi.org/10.1007/s40259-026-00768-y) Real‑World Use of Dostarlimab Plus Chemotherapy in Advanced or Recurrent Endometrial Cancer: A Nationwide Cohort Study in France Allison Singier1 · Stéphane Vignot2 · David Desplas1 · Mahmoud Zureik1 · Nadia Haddy1 Accepted: 6 February 2026 / Published online: 3 March 2026 © The Author(s) 2026, modified publication 2026 Abstract Background Dostarlimab, a PD-1 inhibitor, was initially approved in Europe in 2021 for advanced or recurrent mismatch repairdeficient/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 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. 1 Background The therapeutic arsenal for advanced or recurrent endometrial cancer has recently evolved. While carboplatin-paclitaxel chemotherapy, or hormonal therapy, has long been the standard first-line therapy [1, 2], immunotherapy has recently emerged as an alternative, particularly in mismatch repair-deficient/microsatellite instability-high (dMMR/MSIH) endometrial cancer. In Europe, endometrial cancer ranks as the third most common cancer among women, with a prevalence of 29 per 100,000 and approximately 125,000 Extended author information available on the last page of the article new cases diagnosed each year [1]. The median age at diagnosis is 68 years, and nearly one quarter of patients present with advanced or metastatic disease, for whom the prognosis remains poor with conventional treatment [3] . Dostarlimab, a PD-1 immune checkpoint inhibitor, initially demonstrated clinical efficacy as monotherapy in the phase I GARNET study [4] . More recently, the phase III RUBY trial showed that the combination of dostarlimab with carboplatin-paclitaxel as induction therapy, followed by dostarlimab maintenance significantly improved progression-free survival (PFS), with a median of 11.8 months (95%

FAQs

What was the main objective of the nationwide cohort study?

To describe patients’ characteristics, survival, and safety outcomes of dostarlimab plus chemotherapy in advanced or recurrent endometrial cancer treated in real-world clinical practice.

How was overall survival and progression-free survival estimated?

Overall survival (OS) and real-world progression-free survival (rwPFS) were estimated using the Kaplan–Meier method, with rwPFS defined by subsequent treatment, palliative care, or death.

What did the study find about survival and treatment discontinuation?

Median OS was not reached; 1-year OS probability was 72.8%. Time to treatment discontinuation and rwPFS were lower, with median values of 8.6 and 9.7 months, respectively, and 1-year survival probabilities of 35.7% and 44.4%.

Sep 22, 2026

Uploaded by Rhys