Pts with non-squamous NSCLC in the chemo-alone arm could receive pemetrexed maintenance. Methods: Adult patients (pts) with stage IV / recurrent NSCLC, ECOG performance status ≤ 1, and no known sensitizing EGFR/ALK alterations were stratified by PD-L1 (< 1% vs ≥ 1%), sex, and histology (squamous vs non-squamous) and were randomized 1:1 to NIVO 360 mg Q3W + IPI 1 mg/kg Q6W + chemo (2 cycles n = 361) or chemo alone (4 cycles n = 358). Here we report data with 2 years’ minimum follow-up from this study. Clinical benefit was observed regardless of programmed death ligand 1 (PD-L1) expression level and histology. Airway Research Center North, German Center for Lung Research, LungClinic, Grosshansdorf, Germany, Institutul oncologic Prof Dr Ion Chiricuta and UMF Iuliu Hatieganu, Cluj-Napoca, Romania, Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen de la Victoria, IBIMA, Málaga, Spain, SF Nectarie Oncology Center, Craiova, Romania, Ambulatorium Chemioterapii, Bydgoszcz, Poland, Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil, Instituto Oncológico de Córdoba, Córdoba, Argentina, University Hospital of Nantes and INSERM, CRCINA, Nantes, France, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology, Barcelona, Spain, Hospital Universitario La Fe, Valencia, Spain, Institute of Oncology Prof Dr Alexandru Trestioreanu Bucha, Bucharest, Romania, Saitama Cancer Center, Saitama, Japan, University of Lille, CHU Lille, INSERM U1189, OncoThAI, Lille, France, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China, Hospital Universitario 12 de Octubre, CNIO-H12o Lung Cancer Clinical Research Unit, Universidad Complutense & CiberOnc, Madrid, Spain, The Ohio State University Comprehensive Cancer Center, Columbus, OH, Bristol Myers Squibb, Princeton, NJ, Bristol Myers Squibb, Springfield, PA, Austin Hospital, Heidelberg, Australia Abstract Disclosuresīackground: In the randomized phase 3 CheckMate 9LA trial (NCT03215706), first-line NIVO + IPI combined with 2 cycles of chemo significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) vs chemo alone (4 cycles).
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