Overall survival in patients with endometrial cancer treated with dostarlimab plus carboplatin–paclitaxel in the randomized ENGOT-EN6/GOG-3031/RUBY trial

• DOI: 10.1016/j.annonc.2024.05.546
• Publication Date: 2024-06-10T05:44:20Z
• Authors: M.A. Powell; L. Bjørge; L. Willmott; Z. Novák; D. Black; L. Gilbert; S. Sharma; G. Valabrega; L.M. Landrum; M. Gropp-Meier; A. Stuckey; I. Boere; M.A. Gold; Y. Segev; S.E. Gill; C. Gennigens; A. Sebastianelli; M.S. Shahin; B. Pothuri; B.J. Monk; J. Buscema; R.L. Coleman; B.M. Slomovitz; K.L. Ring; T.J. Herzog; M.M. Balas; M. Grimshaw; S. Stevens; D.W. Lai; C. McCourt; M.R. Mirza
• Keywords: Carboplatin; Interim analysis; Clinical endpoint; Progression-free survival

BackgroundPart 1 of the RUBY trial (NCT03981796) evaluated dostarlimab plus carboplatin-paclitaxel compared with placebo in patients primary advanced or recurrent endometrial cancer. At first interim analysis, met one its dual-primary endpoints statistically significant progression-free survival benefits mismatch repair deficient/microsatellite instability–high (dMMR/MSI-H) and overall populations. Overall (OS) results are reported from second analysis.Patients MethodsRUBY is a phase 3, global, double-blind, randomized, placebo-controlled trial. Part enrolled eligible stage III IV cancer who were randomly assigned (1:1) to receive either (500 mg) placebo, every 3 weeks for 6 cycles followed by (1000 up years. OS was endpoint.ResultsA total 494 randomized (245 arm; 249 arm). In population, 51% maturity, endpoint at this reduction risk death (HR = 0.69; 95% CI, 0.54-0.89; P 0.0020) treated versus alone. The lower dMMR/MSI-H population 0.32; 0.17-0.63; nominal 0.0002) trend favor seen proficient/microsatellite stable (MMRp/MSS) 0.79; 0.60-1.04; 0.0493). safety profile consistent analysis.ConclusionsDostarlimab combination demonstrated clinically meaningful benefit while demonstrating an acceptable profile.