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In TPS ≥50%, PFS HRs were similar across archival and newly collected samples. In patients with TPS ≥1%, OS HRs were 0.74 (95% CI: 0.59, 0.93) and 0.59 (95% CI: 0.48, 0.73) for archival and newly collected samples, respectively. Approximately 40% of archival samples and 45% of newly collected tumor samples were PD-L1 TPS ≥50%. Of 1033 patients analyzed, 455(44%) were enrolled based on archival samples and 578 (56%) on newly collected tumor samples. Pembrolizumab versus docetaxel continued to improve OS in patients with previously treated, PD-L1-expressing advanced NSCLC hazard ratio (HR) was 0.66. Primary end points were OS and progression-free survival (PFS) in tumor proportion score (TPS) ≥50% and ≥1% pembrolizumab doses were pooled in this analysis.Īt date cut-off of 24 March 2017, median follow-up was 31 months (range 23-41) representing 18 additional months of follow-up from the primary analysis. Response was assessed by RECIST v1.1 every 9 weeks, survival every 2 months. Patients received pembrolizumab 2 or 10 mg/kg Q3W or docetaxel 75 mg/m2 Q3W for 24 months or until progression/intolerable toxicity/other reason. PD-L1 was assessed centrally by immunohistochemistry (22C3 antibody) in archival or newly collected tumor samples. A prespecified exploratory analysis compared outcomes in patients based on PD-L1 expression in archival versus newly collected tumor samples using recently updated survival data. In KEYNOTE-010, pembrolizumab versus docetaxel improved overall survival (OS) in patients with programmed death-1 protein (PD)-L1-positive advanced non-small-cell lung cancer (NSCLC). 17 Department of Medicine, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, USA.16 Department of Clinical Research, Merck & Co.15 Department of Hemato-Oncology, Pontificia Universidad Católica de Chile, Santiago, Chile.14 Department of Medical Oncology, Instituto do Câncer do Estado de São Paulo, Sao Paulo, Brazil.13 Department of Respiratory Medicine/Thoracic Oncology, Universitar Ziekenhuis Ghent, Ghent, Belgium.12 Division of Hematology Oncology, Rush University Medical Center, Chicago, USA.11 Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.10 Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.9 Department of Medicine, Centre François Baclesse, Caen, France.8 Department of Medical Oncology, CHA Bundang Medical Center, CHA University, Gyeonggi-Do, Republic of Korea.7 Department of Oncology, Mayo Clinic, Rochester, USA.6 Division of Translational & Clinical Research, National Cancer Center, Goyang, Republic of Korea.5 Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.4 Lung Cancer Unit, Department of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain Vall d'Hebron Institute of Oncology, Barcelona, Spain.3 Department of Oncology, Clinica Universidad de Navarra, Pamplona, Spain.Electronic address: 2 Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands. 1 Department of Medical Oncology, Yale University School of Medicine, Yale Comprehensive Cancer Center, New Haven, USA.