Five-year OS rates were 19.4% versus 11.3% in the intention-to-treat population. We examined whether patients with previously untreated metastatic nonsquamous non–small-cell lung cancer without EGFR/ALK alterations treated with pembrolizumab plus pemetrexed and platinum chemotherapy continue to experience improved survival outcomes versus placebo plus pemetrexed and platinum chemotherapy after 5 years of follow-up.Īfter 5 years, pembrolizumab plus pemetrexed-platinum was associated with improved overall survival (OS) and progression-free survival compared with placebo plus pemetrexed-platinum in patients with metastatic nonsquamous non–small-cell lung cancer, regardless of programmed cell death ligand-1 expression. These data continue to support pembrolizumab plus pemetrexed-platinum as a standard of care in previously untreated metastatic non–small-cell lung cancer without EGFR/ALK alterations.© 2023 by American Society of Clinical Oncology Pembrolizumab plus pemetrexed-platinum maintained OS and PFS benefits versus placebo plus pemetrexed-platinum, regardless of programmed cell death ligand-1 expression. Among 57 patients who completed 35 cycles of pembrolizumab, objective response rate was 86.0% and 3-year OS rate after completing 35 cycles (approximately 5 years after random assignment) was 71.9%. Hazard ratio (95% CI) for OS was 0.60 (0.50 to 0.72) and PFS was 0.50 (0.42 to 0.60) for pembrolizumab plus platinum-pemetrexed versus placebo plus platinum-pemetrexed. Among 616 randomly assigned patients (n = 410, pembrolizumab plus pemetrexed-platinum n = 206, placebo plus pemetrexed-platinum), median time from random assignment to data cutoff (March 8, 2022) was 64.6 (range, 60.1-72.4) months. Primary end points were overall survival (OS) and progression-free survival (PFS). Eligible patients with previously untreated metastatic nonsquamous non–small-cell lung cancer without EGFR/ALK alterations were randomly assigned 2:1 to pembrolizumab 200 mg or placebo once every 3 weeks for up to 35 cycles with pemetrexed and investigator's choice of carboplatin/cisplatin for four cycles, followed by maintenance pemetrexed until disease progression or unacceptable toxicity. We present 5-year outcomes from the phase 3 KEYNOTE-189 study ( identifier: NCT02578680). Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. The initial report, typically on the based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. 1Knapp Center for Biomedical Discovery, University of Chicago Medicine & Biological Sciences, Chicago, ILĢFondazione IRCCS Istituto Nazionale dei Tumori, Milan, ItalyģHenry Ford Cancer Institute/Henry Ford Health, Detroit, MIĤCentre Integré de Cancérologie de la Montérégie, Hôpital Charles-Le Moyne, Greenfield Park, QC, CanadaĥMedical Oncology Department, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, SpainĦDepartment of Medical Oncology, Hospital Universitario Central de Asturias, Oviedo, SpainħDepartment of Oncology, Hospital Universitario Fundación Jiménez Díaz, IIS-FJD, Madrid, SpainĨDepartment of Respiratory and Critical Care Medicine, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, AustriaĩHematology and Oncology, Sanford Cancer Center, Sioux Falls, SDġ1Department of Oncology, Shaare Zedek Medical Center, Jerusalem, Israelġ2Medical Oncology Division, University of Insubria, Varese, Italyġ3Department of Medical Oncology, Epworth Healthcare, Richmond, VIC, Australiaġ4LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germanyġ5Department of Medical Oncology, Westmead Hospital and University of Sydney, Sydney, NSW, Australiaġ6Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CAġ7Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japanġ8Department of Thoracic Oncology, Moffitt Cancer Center, Tampa, FLĢ0Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, SpainĬlinical trials frequently include multiple end points that mature at different times.
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