Background: Dostarlimab (DOST) + carboplatin-paclitaxel (CP) demonstrated significant progression-free survival (PFS) and overall survival (OS) benefits in patients with mismatch repair–deficient/high microsatellite instability (dMMR/MSI-H) primary advanced or recurrent endometrial cancer (EC) in the RUBY trial (NCT03981796). Here, we report updated efficacy with 4 years of follow-up in patients with dMMR/MSI-H EC and characteristics of patients with long-term disease control.
Methods: Patients were randomized (1:1) to receive DOST+CP or placebo (PBO)+CP every 3 weeks (6 cycles) followed by DOST or PBO monotherapy every 6 weeks for up to 3 years or until disease progression. Descriptive analyses of PFS and OS were conducted. In this post hoc analysis, for patients treated with DOST+CP who achieved complete response (CR) or long-term (≥3 years) disease control, clinical characteristics, treatment duration, and RECIST v1.1 responses (CR/partial response [PR]/stable disease [SD]) were reported at 1 year landmark intervals. Funding: GSK
Results: Overall, 53 patients were treated with DOST+CP and 65 received PBO+CP. Median follow-up: 55.6 months. DOST+CP vs PBO+CP demonstrated sustained OS (hazard ratio [HR] 0.34, 95% CI 0.19–0.63; 4-year OS rate: 72.8% vs 40.3%) and PFS (HR 0.30; 95% CI, 0.17–0.52; 4-year PFS rate: 57.9% vs 15.7%) benefits. Median PFS and OS in the DOST+CP arm were not reached. Only 4 new progression events occurred within 2.5 years after the primary PFS analysis (23/09/2022). Of patients treated with DOST+CP, 17 achieved CR, of whom few progressed (3/17) or died (1/17). Only 1/12 patients with CR at 1 year had progression at 4 years. Sustained clinical benefit was observed across disease responses (CR/PR/SD).
Conclusion: The high rate of durable remission suggests the potential for long-term management and disease control with DOST+CP in this patient population.
Previously presented at ESMO Gynaecological Cancer 2026, FPN:71R0, Vladyslav Sukhin et al. Reused with permission.