![]() Bariani: Financial Interests, Personal, Funding: Mabxience Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA Bristol Myers Squibb Financial Interests, Personal, Advisory Role: Libbs. O'Malley: Financial Interests, Personal, Advisory Board: AstraZeneca, Tesaro/GSK, BBI, Immunogen, Ambry, Janssen/J&J, Abbvie, Regeneron, Amgen, Novocure, Genentech/Roche, GOGFoundation, Iovance Biotherapeutics, Inc, Myriad Genetics, Eisai, Agenus, Tarveda, Merck & Co., Inc., Kenilworth, NJ, USA, SeaGen, Novart Financial Interests, Institutional, Funding: AstraZeneca, Tesaro/GSK, Immunogen, Janssen/J&J, Abbvie, Regeneron, Amgen, Novocure, Genentech/Roche, VentiRx, Array Biopharma, EMD Serono, Ergomed, Ajinomoto Inc., Ludwig Cancer Research, Stemcentrx, Inc, Cerulean Pharma, GOGFoundation, NCI, Bristol Mye. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Writing support was provided by Christabel Wilson, MSc, of ICON plc (North Wales, PA, USA), funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. “+” indicates there was no PD by the time of last disease assessment. Pembro demonstrated robust and durable ORR (48% CR, 14%), encouraging survival outcomes and manageable toxicity in pts with heavily pretreated, advanced MSI-H/dMMR EC, and is a promising treatment option in this setting. 25 pts (28%) had immune-mediated AEs and infusion reactions (grade 3–4, 7% no grade 5). 68/90 pts (76%) had treatment-related AEs (grade 3–4, 12% no grade 5), and led to discontinuation in 7%. ORR was 48%, with DOR ≥3 y in 68% see the table for results. In the efficacy population (n = 79), median time from first dose to data cutoff was 42.6 (range, 6.4–56.1) mo 41 (52%) had ≥2 lines of prior therapy and 61% had ECOG PS 1. ResultsĪs of Oct 5, 2020, 18/90 pts (20%) had completed 35 cycles of pembro and 52 (58%) had discontinued treatment. Efficacy was assessed in pts who received ≥1 pembro dose and had ≥26 wk follow up and safety in all treated pts. Secondary endpoints included DOR, PFS, OS, and safety. ![]() Primary endpoint was ORR per RECIST v1.1 by independent central radiologic review. Pts received pembro 200 mg Q3W for up to 35 cycles. In cohort K, MSI-H/dMMR output was determined prospectively by PCR and/or IHC at a local lab, respectively. In cohort D, MSI-H expression was determined retrospectively by PCR at a central lab. Pts from cohorts D (EC, regardless of MSI-H status) and K (any MSI-H/dMMR solid tumor, except colorectal) were ≥18 y, had previously treated, advanced MSI-H/dMMR EC, measurable disease per RECIST v1.1, ECOG PS 0/1 and provided a tumor sample for biomarker analysis. ![]() We present longer follow up in more pts from KEYNOTE-158. ORR of 57% was observed in 49 pts with MSI-H/dMMR EC in KEYNOTE-158. Pembro showed durable and clinically meaningful benefit in previously treated, advanced MSI-H/dMMR tumors, including EC, in the nonrandomized, open-label, phase II KEYNOTE-158 study (NCT02628067). Treatment options for previously treated, advanced MSI-H or mismatch repair deficient (dMMR) tumors are limited. 13 Division Of Medical Oncology And Immunotherapy, Center for Immuno-Oncology, Department of Oncology, University Hospital of Siena, Siena/IT.12 Oncology, Merck & Co., Inc., Kenilworth/US.11 Biostatistics, Merck & Co., Inc., Kenilworth/US.10 Department Of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne/AU.9 Early Phase Trials And Sarcoma Units, Institut Bergonie, Bordeaux/FR.8 Oncology Department, Tel Aviv Medical Center, Tel Aviv and Sackler School of Medicine, Tel Aviv University, Tel Aviv/IL.7 Segal Cancer Centre, Jewish General Hospital, Rossy Cancer Network and Departments of Oncology and Medicine, McGill University, Montreal/CA.6 Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore/US.5 Division Of Medical Oncology, Princess Margaret Cancer Centre, Toronto/CA.4 Drug Development Department, Gustave Roussy, Institut National de la Santé et de la Recherche Médicale U1015, Villejuif/FR.3 Department Of Medical Oncology, Centre Léon Bérard, Lyon/FR.2 Department Of Medical Oncology, Instituto do Câncer do Estado de São Paulo, Universidade de São Paulo, São Paulo/BR.1 Division Of Gynecologic Oncology, The Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center, 43210 - Columbus/US.
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