{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:28:14Z","timestamp":1792787294736,"version":"4.5.0"},"reference-count":40,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2024,2,10]],"date-time":"2024-02-10T00:00:00Z","timestamp":1707523200000},"content-version":"unspecified","delay-in-days":9,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Bristol Myers Squibb","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2023,12,27]]},"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>In CheckMate 9LA, nivolumab plus ipilimumab with chemotherapy prolonged overall survival (OS) versus chemotherapy regardless of tumor PD-L1 expression or histology. We report updated efficacy and safety in all randomized patients with a minimum 4-year follow-up and an exploratory treatment-switching adjustment analysis in all treated patients who received chemotherapy and subsequent immunotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Adults with stage IV\/recurrent non-small cell lung cancer (NSCLC), no sensitizing\n                      <jats:italic>EGFR\/ALK<\/jats:italic>\n                      alterations, and ECOG performance status \u22641 were randomized 1:1 to nivolumab 360\u2009mg every 3 weeks plus ipilimumab 1\u2009mg\/kg every 6 weeks with chemotherapy (two cycles) or chemotherapy (four cycles, with optional maintenance pemetrexed for the nonsquamous population). Assessments included OS, progression-free survival, and objective response rate. Exploratory analyses included efficacy by tumor PD-L1 expression and histology and in patients who discontinued nivolumab plus ipilimumab with chemotherapy due to treatment-related adverse events (TRAEs), and a treatment-switching adjustment analysis using inverse probability of censoring weighting.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>With a 47.9-month minimum follow-up for OS, nivolumab plus ipilimumab with chemotherapy continued to prolong OS over chemotherapy in all randomized patients (HR 0.74, 95%\u2009CI 0.63 to 0.87; 4-year OS rate: 21% versus 16%), regardless of tumor PD-L1 expression (HR (95%\u2009CI): PD-L1&lt;1%, 0.66 (0.50 to 0.86) and \u22651%, 0.74 (0.60 to 0.92)) or histology (squamous, 0.64 (0.48 to 0.84) and non-squamous, 0.80 (0.66 to 0.97)). In patients who discontinued all components of nivolumab plus ipilimumab with chemotherapy due to TRAEs (n=61), the 4-year OS rate was 41%. With treatment-switching adjustment for the 36% of patients receiving subsequent immunotherapy in the chemotherapy arm, the estimated HR of nivolumab plus ipilimumab with chemotherapy versus chemotherapy was 0.66 (95% CI 0.55 to 0.80). No new safety signals were observed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this 4-year update, patients treated with nivolumab plus ipilimumab with chemotherapy continued to have long-term, durable efficacy benefit over chemotherapy regardless of tumor PD-L1 expression and\/or histology. A greater estimated relative OS benefit was observed after adjustment for subsequent immunotherapy use in the chemotherapy arm. These results further support nivolumab plus ipilimumab with chemotherapy as a first-line treatment for patients with metastatic\/recurrent NSCLC, including those with tumor PD-L1&lt;1%\u2009or squamous histology, populations with high unmet needs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/jitc-2023-008189","type":"journal-article","created":{"date-parts":[[2024,2,12]],"date-time":"2024-02-12T12:35:31Z","timestamp":1707741331000},"page":"e008189","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":58,"title":["Four-year clinical update and treatment switching-adjusted outcomes with first-line nivolumab plus ipilimumab with chemotherapy for metastatic non-small cell lung cancer in the CheckMate 9LA randomized trial"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct03215706","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3002-1921","authenticated-orcid":false,"given":"David P.","family":"Carbone","sequence":"first","affiliation":[{"name":"Division of Medical Oncology and the Pelotonia Institute for Immuno-Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tudor-Eliade","family":"Ciuleanu","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Institutul Oncologic Prof Dr Ion Chiricut\u0103 and University of Medicine and Pharmacy Iuliu Ha\u0163ieganu, Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Schenker","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, SF Nectarie Oncology Center, Craiova, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel","family":"Cobo","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Unidad de Gesti\u00f3n Cl\u00ednica Intercentros de Oncolog\u00eda M\u00e9dica, Hospitales Universitarios Regional y Virgen de la Victoria, IBIMA, M\u00e1laga, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phanie","family":"Bordenave","sequence":"additional","affiliation":[{"name":"L\u2019institut du Thorax, Nantes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oscar","family":"Juan-Vidal","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Hospital Universitario La Fe, Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juliana","family":"Menezes","sequence":"additional","affiliation":[{"name":"Department of Oncology, Hospital Nossa Senhora da Concei\u00e7\u00e3o, Porto Alegre, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niels","family":"Reinmuth","sequence":"additional","affiliation":[{"name":"Department of Oncology, Asklepios Lung Clinic, German Center for Lung Research, Munich-Gauting, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eduardo","family":"Richardet","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology, IONC Instituto Oncol\u00f3gico de C\u00f3rdoba, C\u00f3rdoba, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Cheng","sequence":"additional","affiliation":[{"name":"Department of Oncology, Jilin Cancer Hospital, Changchun, Jilin, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideaki","family":"Mizutani","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enriqueta","family":"Felip","sequence":"additional","affiliation":[{"name":"Medical Oncology Service, Vall d\u2019Hebron University Hospital, Vall d\u2019Hebron Institute of Oncology, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bogdan","family":"Zurawski","sequence":"additional","affiliation":[{"name":"Chemotherapy Department, Ambulatorium Chemioterapii, Bydgoszcz, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aurelia","family":"Alexandru","sequence":"additional","affiliation":[{"name":"Department of Oncology, Institute of Oncology Prof Dr Alexandru Trestioreanu Bucha, Bucharest, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis","family":"Paz-Ares","sequence":"additional","affiliation":[{"name":"Medical Oncology Department, Hospital Universitario 12 de Octubre, Universidad Complutense de Madrid, Madrid, 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NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2023."},{"key":"2025100302174698000_12.2.e008189.2","doi-asserted-by":"crossref","first-page":"e51","DOI":"10.1200\/JCO.23.00282","article-title":"Therapy for stage IV non-small-cell lung cancer without driver alterations: ASCO living guideline, version 2023.1","volume":"41","author":"Singh","year":"2023","journal-title":"J Clin Oncol"},{"key":"2025100302174698000_12.2.e008189.3","doi-asserted-by":"crossref","first-page":"358","DOI":"10.1016\/j.annonc.2022.12.013","article-title":"Non-oncogene-addicted metastatic non-small-cell lung cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up","volume":"34","author":"Hendriks","year":"2023","journal-title":"Ann Oncol"},{"key":"2025100302174698000_12.2.e008189.4","doi-asserted-by":"crossref","first-page":"204","DOI":"10.1016\/j.jtho.2022.10.014","article-title":"First-line nivolumab plus ipilimumab with chemotherapy versus chemotherapy alone for metastatic NSCLC in CheckMate 9LA: 3-year clinical update and outcomes in patients with brain metastases or select somatic mutations","volume":"18","author":"Paz-Ares","year":"2023","journal-title":"J Thorac Oncology"},{"key":"2025100302174698000_12.2.e008189.5","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.21.02229"},{"key":"2025100302174698000_12.2.e008189.6","doi-asserted-by":"crossref","first-page":"2085","DOI":"10.1002\/cncr.34180","article-title":"Conditional survival and long-term efficacy with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma","volume":"128","author":"Motzer","year":"2022","journal-title":"Cancer"},{"key":"2025100302174698000_12.2.e008189.7","doi-asserted-by":"crossref","first-page":"S1438","DOI":"10.1016\/j.annonc.2022.08.077","article-title":"First-line nivolumab (NIVO) plus ipilimumab (IPI) versus chemotherapy (chemo) in patients (pts) with unresectable malignant pleural mesothelioma (uMPM): 4-year update from CheckMate 743","volume":"33","author":"Zalcman","year":"2022","journal-title":"Ann Oncol"},{"key":"2025100302174698000_12.2.e008189.8","doi-asserted-by":"crossref","first-page":"1200","DOI":"10.1200\/JCO.22.01503","article-title":"Five-year survival outcomes with nivolumab plus ipilimumab versus chemotherapy as first-line treatment for metastatic non-small-cell lung cancer in CheckMate 227","volume":"41","author":"Brahmer","year":"2023","journal-title":"J Clin Oncol"},{"key":"2025100302174698000_12.2.e008189.9","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.21.00174"},{"key":"2025100302174698000_12.2.e008189.10","doi-asserted-by":"crossref","first-page":"1992","DOI":"10.1200\/JCO.22.01989","article-title":"Pembrolizumab plus pemetrexed and platinum in nonsquamous non-small-cell lung cancer: 5-year outcomes from the phase 3 KEYNOTE-189 study","volume":"41","author":"Garassino","year":"2023","journal-title":"J Clin Oncol"},{"key":"2025100302174698000_12.2.e008189.11","doi-asserted-by":"crossref","first-page":"1999","DOI":"10.1200\/JCO.22.01990","article-title":"Pembrolizumab plus chemotherapy in squamous non-small-cell lung cancer: 5-year update of the phase III KEYNOTE-407 study","volume":"41","author":"Novello","year":"2023","journal-title":"J Clin Oncol"},{"key":"2025100302174698000_12.2.e008189.12","doi-asserted-by":"crossref","first-page":"S77","DOI":"10.1016\/j.jtho.2023.09.078","article-title":"5-year survival of pembrolizumab plus chemotherapy for metastatic NSCLC with PD-L1 tumor proportion score <1%","volume":"18","author":"Gadgeel","year":"2023","journal-title":"J Thoracic Oncol"},{"key":"2025100302174698000_12.2.e008189.13","unstructured":"O\u2019Byrne K , Popoff E , Badin F , et al . 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