{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T06:57:04Z","timestamp":1784185024845,"version":"3.55.0"},"reference-count":32,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2024,10,23]],"date-time":"2024-10-23T00:00:00Z","timestamp":1729641600000},"content-version":"unspecified","delay-in-days":22,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Nahyan Foundation"},{"name":"Bob Mayberry Foundation"},{"name":"MD Anderson Cancer Center Physician Scientist Program"},{"name":"Rexanna\u2019s Foundation for Fighting Lung Cancer"},{"name":"NIH\/NCI","award":["P30 CA016672"],"award-info":[{"award-number":["P30 CA016672"]}]},{"name":"NIH\/NCI","award":["R01CA262425"],"award-info":[{"award-number":["R01CA262425"]}]},{"name":"NIH\/NCI","award":["U01CA264583"],"award-info":[{"award-number":["U01CA264583"]}]},{"DOI":"10.13039\/100020046","name":"Khalifa Bin Zayed Al Nahyan Foundation","doi-asserted-by":"publisher","award":["Khalifa Scholar Award"],"award-info":[{"award-number":["Khalifa Scholar Award"]}],"id":[{"id":"10.13039\/100020046","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100012287","name":"Andrew Sabin Family Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100012287","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000982","name":"Conquer Cancer Foundation of the American Society of Clinical Oncology","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000982","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Lung Specialized Program of Research Excellence SPORE","award":["5P50CA070907"],"award-info":[{"award-number":["5P50CA070907"]}]},{"name":"MD Anderson Cancer Center Lung Cancer Moon Shot Program"},{"name":"Bristol Myers Squibb"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2024,9,21]]},"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Neoadjuvant immune checkpoint inhibitors (ICIs) have improved survival outcomes compared with chemotherapy in resectable non-small cell lung cancer (NSCLC). However, the impact of actionable genomic alterations (AGAs) on the efficacy of neoadjuvant ICIs remains unclear. We report the influence of AGAs on treatment failure (TF) in patients with resectable NSCLC treated with neoadjuvant ICIs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Tumor molecular profiles were obtained from patients with stage I\u2013IIIA resectable NSCLC (American Joint Committee on Cancer seventh edition) treated with either neoadjuvant nivolumab (N, n=23) or nivolumab+ipilimumab (NI, n=21) followed by surgery in a previously reported phase-2 randomized study (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03158129\">NCT03158129<\/jats:ext-link>). TF was defined as any progression of primary lung cancer after neoadjuvant ICI therapy in patients without surgery, radiographic and\/or biopsy-proven primary lung cancer recurrence after surgery, or death from possibly treatment-related complications or from primary lung cancer since randomization. Tumors with AGAs (n=12) were compared with tumors without AGAs and non-profiled squamous cell carcinomas (non-AGAs+NP\u2009SCC, n=20).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>With a median follow-up of 60.2 months, the overall TF rate was 34.1% (15\/44). Tumor molecular profiling was retrospectively obtained in 47.7% (21\/44) of patients and select AGAs were identified in 12 patients: 5 epidermal growth factor receptor <jats:italic>(EGFR)<\/jats:italic>, 2 <jats:italic>KRAS<\/jats:italic>, 1 <jats:italic>ERBB2<\/jats:italic>, and 1 <jats:italic>BRAF<\/jats:italic> mutations, 2 anaplastic lymphoma kinase <jats:italic>(ALK)<\/jats:italic> and 1 <jats:italic>RET<\/jats:italic> fusions. The median time to TF in patients with AGAs was 24.7 months (95%\u2009CI: 12.6 to 40.4), compared with not reached (95%\u2009CI: not evaluable (NE)\u2013NE) in the non-AGAs+NP\u2009SCC group. The TF risk was higher in AGAs (HR: 5.51, 95%\u2009CI: 1.68 to 18.1), and lower in former\/current smokers (HR: 0.24, 95%\u2009CI: 0.08 to 0.75). The odds of major pathological response were 4.71 (95% CI: 0.49 to 45.2) times higher in the non-AGAs+NP\u2009SCC group, and the median percentage of residual viable tumor was 72.5% in AGAs compared with 33.0% in non-AGS+NP\u2009SCC tumors.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Patients with NSCLC harboring select AGAs, including <jats:italic>EGFR<\/jats:italic> and <jats:italic>ALK<\/jats:italic> alterations, have a higher risk for TF, shorter median time to TF, and diminished pathological regression after neoadjuvant ICIs. The suboptimal efficacy of neoadjuvant chemotherapy-sparing, ICI-based regimens in this patient subset underscores the importance of tumor molecular testing prior to initiation of neoadjuvant ICI therapy in patients with resectable NSCLC.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/jitc-2024-009677","type":"journal-article","created":{"date-parts":[[2024,10,23]],"date-time":"2024-10-23T23:40:25Z","timestamp":1729726825000},"page":"e009677","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":9,"title":["Impact of select actionable genomic alterations on efficacy of neoadjuvant immunotherapy in resectable non-small cell lung cancer"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct03158129","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03433469","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04351555","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04302025","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8340-9113","authenticated-orcid":false,"given":"Nicolas","family":"Zhou","sequence":"first","affiliation":[{"name":"Department of Thoracic and Cardiovascular Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheuk H","family":"Leung","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"William N","family":"William","sequence":"additional","affiliation":[{"name":"Department of Thoracic and Head and Neck Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"},{"name":"Grupo Oncocl\u00ednicas, Sao Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annikka","family":"Weissferdt","sequence":"additional","affiliation":[{"name":"Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Apar","family":"Pataer","sequence":"additional","affiliation":[{"name":"Department of Thoracic and Cardiovascular Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myrna C B","family":"Godoy","sequence":"additional","affiliation":[{"name":"Department of Thoracic 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