{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T17:40:01Z","timestamp":1793122801174,"version":"4.5.0"},"reference-count":30,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"12","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2025,4,20]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Neoadjuvant immune checkpoint blockade with nivolumab plus ipilimumab improves overall survival (OS) in non\u2013small cell lung cancer (NSCLC); however, randomized data for resectable lung cancer are limited. We report results from the exploratory concurrently randomized nivolumab plus ipilimumab and chemotherapy arms of the international phase III CheckMate 816 trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>Adults with stage IB-IIIA (American Joint Committee on Cancer seventh edition) resectable NSCLC received three cycles of nivolumab once every 2 weeks plus one cycle of ipilimumab or three cycles of chemotherapy (on day 1 or days 1 and 8 of each 3-week cycle) followed by surgery. Analyses included event-free survival (EFS), OS, pathologic response, surgical outcomes, biomarker analyses, and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>A total of 221 patients were concurrently randomly assigned to nivolumab plus ipilimumab (n = 113) or chemotherapy (n = 108). At a median follow-up of 49.2 months, the median EFS was 54.8 months (95% CI, 24.4 to not reached [NR]) with nivolumab plus ipilimumab versus 20.9 months (95% CI, 14.2 to NR) with chemotherapy (HR, 0.77 [95% CI, 0.51 to 1.15]); 3-year EFS rates were 56% versus 44%. Higher rates of EFS events were initially seen, with later benefit favoring nivolumab plus ipilimumab; 3-year OS rates were 73% versus 61% (HR, 0.73 [95% CI, 0.47 to 1.14]); pathologic complete response rates were 20.4% versus 4.6%, respectively. In the respective arms, 83 (74%) and 82 patients (76%) underwent definitive surgery. Grade 3-4 treatment-related adverse events occurred in 14% and 36% of patients, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>Neoadjuvant nivolumab plus ipilimumab showed potential long-term clinical benefit versus chemotherapy, despite early crossing of EFS curves in the preoperative phase and a lower rate of high-grade toxicity.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-24-02239","type":"journal-article","created":{"date-parts":[[2025,1,8]],"date-time":"2025-01-08T15:59:13Z","timestamp":1736351953000},"page":"1453-1462","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":47,"title":["Neoadjuvant Nivolumab Plus Ipilimumab Versus Chemotherapy in Resectable Lung Cancer"],"prefix":"10.1200","volume":"43","clinical-trial-number":[{"clinical-trial-number":"nct02998528","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0928-5244","authenticated-orcid":true,"given":"Mark M.","family":"Awad","sequence":"first","affiliation":[{"name":"Dana-Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6925-6344","authenticated-orcid":true,"given":"Patrick M.","family":"Forde","sequence":"additional","affiliation":[{"name":"The Bloomberg\u2013Kimmel Institute for Cancer Immunotherapy, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9909-2299","authenticated-orcid":true,"given":"Nicolas","family":"Girard","sequence":"additional","affiliation":[{"name":"Institut du Thorax Curie-Montsouris, Institut Curie, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2708-1309","authenticated-orcid":true,"given":"Jonathan","family":"Spicer","sequence":"additional","affiliation":[{"name":"McGill University Health Centre, Montreal, QC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1075-5071","authenticated-orcid":true,"given":"Changli","family":"Wang","sequence":"additional","affiliation":[{"name":"Tianjin Lung Cancer Center, Tianjin Medical University Cancer Institute &amp; Hospital, Tianjin, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8833-7262","authenticated-orcid":true,"given":"Shun","family":"Lu","sequence":"additional","affiliation":[{"name":"Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9860-8505","authenticated-orcid":true,"given":"Tetsuya","family":"Mitsudomi","sequence":"additional","affiliation":[{"name":"Kindai University Faculty of Medicine, Osaka-Sayama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7620-0098","authenticated-orcid":true,"given":"Enriqueta","family":"Felip","sequence":"additional","affiliation":[{"name":"Vall d\u2019Hebron University Hospital, Vall d\u2019Hebron Institute of Oncology, Universitat Aut\u00f2noma Barcelona, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen R.","family":"Broderick","sequence":"additional","affiliation":[{"name":"The Bloomberg\u2013Kimmel Institute for Cancer Immunotherapy, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott J.","family":"Swanson","sequence":"additional","affiliation":[{"name":"Brigham and Women's Hospital, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2443-8395","authenticated-orcid":true,"given":"Julie","family":"Brahmer","sequence":"additional","affiliation":[{"name":"The Bloomberg\u2013Kimmel Institute for Cancer Immunotherapy, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith","family":"Kerr","sequence":"additional","affiliation":[{"name":"Aberdeen Royal Infirmary, Aberdeen, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-4102-7906","authenticated-orcid":true,"given":"Gene B.","family":"Saylors","sequence":"additional","affiliation":[{"name":"Charleston Oncology, Charleston, SC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0757-7094","authenticated-orcid":true,"given":"Ke-Neng","family":"Chen","sequence":"additional","affiliation":[{"name":"Peking University School of Oncology, Beijing Cancer Hospital, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vishwanath","family":"Gharpure","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7137-3953","authenticated-orcid":true,"given":"Jaclyn","family":"Neely","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Balli","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nan","family":"Hu","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6315-7919","authenticated-orcid":true,"given":"Mariano","family":"Provencio Pulla","sequence":"additional","affiliation":[{"name":"Hospital Universitario Puerta de Hierro, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"e_1_3_10_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2202170"},{"key":"e_1_3_10_3_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2024.42.17_suppl.LBA8010"},{"key":"e_1_3_10_4_2","unstructured":"NCCN Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines\u00ae) for non-small cell lung cancer. 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