{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T04:10:59Z","timestamp":1791951059809,"version":"4.3.4"},"reference-count":9,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"11","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2023,4,10]]},"abstract":"<jats:p>Clinical trials frequently include multiple end points that mature at different times. 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. 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.<\/jats:p>\n                  <jats:p>We present 5-year outcomes from the phase 3 KEYNOTE-189 study (ClinicalTrials.gov identifier: NCT02578680 ). Eligible patients with previously untreated metastatic nonsquamous non\u2013small-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. Primary end points were overall survival (OS) and progression-free survival (PFS). 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. 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. 5-year OS rates were 19.4% versus 11.3%. Toxicity was manageable. 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%. Pembrolizumab plus pemetrexed-platinum maintained OS and PFS benefits versus placebo plus pemetrexed-platinum, 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\u2013small-cell lung cancer without EGFR\/ALK alterations.<\/jats:p>","DOI":"10.1200\/jco.22.01989","type":"journal-article","created":{"date-parts":[[2023,2,21]],"date-time":"2023-02-21T16:01:14Z","timestamp":1676995274000},"page":"1992-1998","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":714,"title":["Pembrolizumab Plus Pemetrexed and Platinum in Nonsquamous Non\u2013Small-Cell Lung Cancer: 5-Year Outcomes From the Phase 3 KEYNOTE-189 Study"],"prefix":"10.1200","volume":"41","clinical-trial-number":[{"clinical-trial-number":"nct02578680","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3821-5598","authenticated-orcid":false,"given":"Marina C.","family":"Garassino","sequence":"first","affiliation":[{"name":"Knapp Center for Biomedical Discovery, University of Chicago Medicine & Biological Sciences, Chicago, IL"},{"name":"Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5240-3811","authenticated-orcid":false,"given":"Shirish","family":"Gadgeel","sequence":"additional","affiliation":[{"name":"Henry Ford Cancer Institute\/Henry Ford Health, Detroit, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanna","family":"Speranza","sequence":"additional","affiliation":[{"name":"Centre Integr\u00e9 de Canc\u00e9rologie de la Mont\u00e9r\u00e9gie, H\u00f4pital Charles-Le Moyne, Greenfield Park, QC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7620-0098","authenticated-orcid":false,"given":"Enriqueta","family":"Felip","sequence":"additional","affiliation":[{"name":"Medical Oncology Department, Vall d\u2019Hebron University Hospital, Vall d\u2019Hebron Institute of Oncology (VHIO), Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilio","family":"Esteban","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Hospital Universitario Central de Asturias, Oviedo, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1128-434X","authenticated-orcid":false,"given":"Manuel","family":"D\u00f3mine","sequence":"additional","affiliation":[{"name":"Department of Oncology, Hospital Universitario Fundaci\u00f3n Jim\u00e9nez D\u00edaz, IIS-FJD, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maximilian J.","family":"Hochmair","sequence":"additional","affiliation":[{"name":"Department of Respiratory and Critical Care Medicine, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5029-0048","authenticated-orcid":false,"given":"Steven F.","family":"Powell","sequence":"additional","affiliation":[{"name":"Hematology and Oncology, Sanford Cancer Center, Sioux Falls, SD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helge G.","family":"Bischoff","sequence":"additional","affiliation":[{"name":"Thoraxklinik, Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3714-4377","authenticated-orcid":false,"given":"Nir","family":"Peled","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shaare Zedek Medical Center, Jerusalem, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8412-3136","authenticated-orcid":false,"given":"Francesco","family":"Grossi","sequence":"additional","affiliation":[{"name":"Medical Oncology Division, University of Insubria, Varese, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9872-997X","authenticated-orcid":false,"given":"Ross R.","family":"Jennens","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Epworth Healthcare, Richmond, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5336-9739","authenticated-orcid":false,"given":"Martin","family":"Reck","sequence":"additional","affiliation":[{"name":"LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rina","family":"Hui","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Westmead Hospital and University of Sydney, Sydney, NSW, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7077-8801","authenticated-orcid":false,"given":"Edward B.","family":"Garon","sequence":"additional","affiliation":[{"name":"Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4123-3567","authenticated-orcid":false,"given":"Takayasu","family":"Kurata","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jhanelle E.","family":"Gray","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology, Moffitt Cancer Center, Tampa, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Schwarzenberger","sequence":"additional","affiliation":[{"name":"Merck & Co, Inc, Rahway, 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