For this analysis, response/PD was assessed by investigators per RECIST v1.1. Endpoints included PFS (primary) OS, ORR, and safety (secondary) and duration of response (exploratory). Pts randomized to pembro who completed 2 years of therapy or who stopped pembro after achieving CR and then had PD were eligible for a second course of pembro monotherapy. Pts randomized to chemo who had PD and met eligibility criteria could cross over to pembro monotherapy. Randomization was stratified by ECOG PS (0/1), histology (squamous/nonsquamous), and region (East Asia/other). MethodsĮligible pts were randomized to pembro (200 mg Q3W for up to 35 cycles ) or chemo. We report updated efficacy and safety from KEYNOTE-024 with 5 years follow-up. Superiority of 1L pembro monotherapy vs chemo in pts with metastatic NSCLC with PD-L1 TPS ≥50% and no sensitizing EGFR/ALK alterations was demonstrated in KEYNOTE-024 (NCT02142738).

16 Lungenclinic, Airway Research Center North, German Center of Lung Research, 22927 - Grosshansdorf/DE.15 Oncology, Merck & Co., Inc., 07033 - Kenilworth/US.14 Division Of Hematology/oncology, UC Davis Comprehensive Cancer Center, Sacramento/US.13 Division Of Hematology & Oncology, Carbone Cancer Center, University of Wisconsin, Madison/US.12 Centre For Innovative Clinical Medicine, Okayama University Hospital, Okayama/JP.11 Medical Oncology, MedStar Franklin Square Hospital, Baltimore/US.10 Medical Oncology, The Royal Marsden Hospital, Sutton, 19454 - Surrey/GB.James’s Hospital and Cancer Trials Ireland (formerly ICORG – All Ireland Cooperative Oncology Research Group), 19454 - Dublin/IE 8 Medical Oncology, Wollongong Private Hospital and University of Wollongong, Wollongong/AU.7 Cancer Center, Soroka University Medical Center, 84101 - Beer Sheva/IL.6 Medical Oncology, Meir Medical Center, Kfar-Saba/IL.5 Medical Oncology, Országos Korányi Pulmonológiai Intézet, Budapest/HU.4 Oncology, Jász-Nagykun-Szolnok County Hospital, Szolnok/HU.3 Medical Oncology, Westmead Hospital and the University of Sydney, 2145 - Sydney/AU.2 Medical Oncology, Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria/ES.1 Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 21287 - Baltimore/US.

Pts 2020