{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T23:03:48Z","timestamp":1793315028415,"version":"4.5.0"},"reference-count":6,"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 based on the primary end point, may be published when key planned co\u2010primary 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 report 5-year results from the phase III KEYNOTE-042 study (ClinicalTrials.gov identifier: NCT02220894 ). Eligible patients with locally advanced\/metastatic non\u2013small-cell lung cancer (NSCLC) without EGFR\/ALK alterations and with programmed death ligand-1 (PD-L1) tumor proportion score (TPS) \u2265 1% received pembrolizumab 200 mg once every 3 weeks for 35 cycles or chemotherapy (carboplatin + paclitaxel or pemetrexed) for 4-6 cycles with optional maintenance pemetrexed. Primary end points were overall survival (OS) in PD-L1 TPS \u2265 50%, \u2265 20%, and \u2265 1% groups. Patients who completed 35 cycles of pembrolizumab with \u2265 stable disease could begin second-course pembrolizumab upon progression. One thousand two hundred seventy\u2010four patients were randomly assigned (pembrolizumab, n = 637; chemotherapy, n = 637). Median follow-up time was 61.1 (range, 50.0-76.3) months. OS outcomes favored pembrolizumab ( v chemotherapy) regardless of PD-L1 TPS (hazard ratio [95% CI] for TPS \u2265 50%, 0.68 [0.57 to 0.81]; TPS \u2265 20%, 0.75 [0.64 to 0.87]; TPS \u2265 1%, 0.79 [0.70 to 0.89]), with estimated 5-year OS rates with pembrolizumab of 21.9%, 19.4%, and 16.6%, respectively. No new toxicities were identified. Objective response rate was 84.3% among 102 patients who completed 35 cycles of pembrolizumab and 15.2% among 33 patients who received second-course pembrolizumab. First-line pembrolizumab monotherapy continued to show durable clinical benefit versus chemotherapy after 5 years of follow-up in PD-L1\u2013positive, locally advanced\/metastatic NSCLC without EGFR\/ALK alterations and remains a standard of care.<\/jats:p>","DOI":"10.1200\/jco.21.02885","type":"journal-article","created":{"date-parts":[[2022,10,28]],"date-time":"2022-10-28T15:59:31Z","timestamp":1666972771000},"page":"1986-1991","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":306,"title":["Five-Year Outcomes With Pembrolizumab Versus Chemotherapy as First-Line Therapy in Patients With Non\u2013Small-Cell Lung Cancer and Programmed Death Ligand-1 Tumor Proportion Score \u2265 1% in the KEYNOTE-042 Study"],"prefix":"10.1200","volume":"41","clinical-trial-number":[{"clinical-trial-number":"nct02220894","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8765-3044","authenticated-orcid":false,"suffix":"Jr","given":"Gilberto","family":"de Castro","sequence":"first","affiliation":[{"name":"Instituto do C\u00e2ncer do Estado de S\u00e3o Paulo, S\u00e3o Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iveta","family":"Kudaba","sequence":"additional","affiliation":[{"name":"Latvian Oncology Center, Riga East Clinical University, Riga, Latvia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3611-0258","authenticated-orcid":false,"given":"Yi-Long","family":"Wu","sequence":"additional","affiliation":[{"name":"Guangdong Lung Cancer Institute, Guangdong Provinicial People's Hospital and Guangdong Academy of Medical Sciences, Guandong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1151-9903","authenticated-orcid":false,"given":"Gilberto","family":"Lopes","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Sylvester Comprehensive Cancer Center at the University of Miami, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9452-3229","authenticated-orcid":false,"given":"Dariusz M.","family":"Kowalski","sequence":"additional","affiliation":[{"name":"Department of Lung Cancer and Chest Tumours, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hande Z.","family":"Turna","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Istanbul University\u2010Cerrahpasa, Cerrahpasa Medical Faculty, Istanbul, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3319-1678","authenticated-orcid":false,"given":"Christian","family":"Caglevic","sequence":"additional","affiliation":[{"name":"Cancer Research Department, Instituto Oncol\u00f3gico Fundaci\u00f3n Arturo L\u00f3pez P\u00e9rez, Santiago, Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Zhang","sequence":"additional","affiliation":[{"name":"Peking Union Medical College Hospital, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boguslawa","family":"Karaszewska","sequence":"additional","affiliation":[{"name":"Przychodnia Lekarska KOMED, Konin, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Konstantin K.","family":"Laktionov","sequence":"additional","affiliation":[{"name":"Federal State Budgetary Institution, \u201cN.N. Blokhin National Medical Research Center of Oncology\u201d of the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO), Moscow, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vichien","family":"Srimuninnimit","sequence":"additional","affiliation":[{"name":"Department of Medicine, Siriraj Hospital, Bangkok, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7071-2471","authenticated-orcid":false,"given":"Igor","family":"Bondarenko","sequence":"additional","affiliation":[{"name":"Oncology and Medical Radiology Department, Dnipro State Medical Academy, Dnipro, Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaoru","family":"Kubota","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Medicine and Oncology, Nippon Medical School Hospital, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rinee","family":"Mukherjee","sequence":"additional","affiliation":[{"name":"Merck & Co, Inc, Rahway, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianxin","family":"Lin","sequence":"additional","affiliation":[{"name":"Merck & Co, Inc, Rahway, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabricio","family":"Souza","sequence":"additional","affiliation":[{"name":"Merck & Co, Inc, Rahway, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8251-0551","authenticated-orcid":false,"given":"Tony S.K.","family":"Mok","sequence":"additional","affiliation":[{"name":"Clinical Oncology, State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Shatin, Hong Kong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5562-270X","authenticated-orcid":false,"given":"Byoung Chul","family":"Cho","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"b1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)32409-7"},{"key":"b2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.21.00174"},{"key":"b3","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.19.00934"},{"key":"b4","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2022.0025"},{"key":"b5","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdy275"},{"key":"b6","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2021.39.15_suppl.9001"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.21.02885","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,4,5]],"date-time":"2023-04-05T18:01:37Z","timestamp":1680717697000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.21.02885"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,4,10]]},"references-count":6,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2023,4,10]]}},"alternative-id":["10.1200\/JCO.21.02885"],"URL":"https:\/\/doi.org\/10.1200\/jco.21.02885","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,4,10]]},"assertion":[{"value":"2021-12-15","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-05-18","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-08-15","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-10-28","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}