In the efficacy population (patients who received ≥ 1 dose of pembrolizumab and had ≥ 26 weeks of follow-up N = 79), the median time from first dose to data cutoff was 42.6 (range, 6.4-56.1) months. Secondary end points included duration of response, progression-free survival, overall survival, and safety.Īs of October 5, 2020, 18 of 90 treated patients (20%) had completed 35 cycles of pembrolizumab and 52 (58%) had discontinued treatment. The primary end point was objective response rate per RECIST version 1.1 by independent central radiologic review. We report efficacy and safety outcomes for patients with MSI-H/dMMR endometrial cancer enrolled in KEYNOTE-158.Įligible patients from cohorts D (endometrial cancer, regardless of MSI-H/dMMR status) and K (any MSI-H/dMMR solid tumor, except colorectal) with previously treated, advanced MSI-H/dMMR endometrial cancer received pembrolizumab 200 mg once every 3 weeks for 35 cycles. Pembrolizumab demonstrated durable antitumor activity in patients with previously treated, advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) tumors, including endometrial cancer, in the nonrandomized, open-label, multicohort, phase II KEYNOTE-158 study ( NCT02628067). 15 Division of Medical Oncology and Immunotherapy, Center for Immuno-Oncology, Department of Oncology, University Hospital of Siena, Siena, Italy.13 Peter MacCallum Cancer Centre and the Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia.12 Faculty of Medicine, University of Bordeaux, France.11 Early Phase Trials and Sarcoma Units, Institut Bergonie, Bordeaux, France.10 Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.9 Oncology Department, Tel Aviv Medical Center, Tel Aviv, Israel.8 Departments of Oncology and Medicine, McGill University, Montreal, QC, Canada.7 Segal Cancer Centre, Jewish General Hospital, Rossy Cancer Network, Montreal, QC, Canada.6 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.5 Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada.4 Département d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Institut National de la Santé et de la Recherche Médicale (INSERM U1015), Gustave Roussy, Université Paris Saclay, Villejuif, France.3 Department of Medical Oncology, Centre Léon Bérard, Lyon, France.

2 Department of Medical Oncology, Instituto do Câncer do Estado de São Paulo, Universidade de São Paulo, São Paulo, Brazil.1 Division of Gynecologic Oncology, The Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center, Columbus, OH.

Keynote 158 trial