{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T06:52:28Z","timestamp":1792479148239,"version":"4.5.0"},"reference-count":52,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"20","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2024,7,10]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>The anti-NECTIN4 antibody-drug conjugate enfortumab vedotin (EV) is approved for patients with metastatic urothelial cancer (mUC). However, durable benefit is only achieved in a small, yet uncharacterized patient subset. NECTIN4 is located on chromosome 1q23.3, and 1q23.3 gains represent frequent copy number variations (CNVs) in urothelial cancer. Here, we aimed to evaluate NECTIN4 amplifications as a genomic biomarker to predict EV response in patients with mUC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>MATERIALS AND METHODS<\/jats:title>\n                    <jats:p>We established a NECTIN4-specific fluorescence in situ hybridization (FISH) assay to assess the predictive value of NECTIN4 CNVs in a multicenter EV-treated mUC patient cohort (mUC-EV, n = 108). CNVs were correlated with membranous NECTIN4 protein expression, EV treatment responses, and outcomes. We also assessed the prognostic value of NECTIN4 CNVs measured in metastatic biopsies of non\u2013EV-treated mUC (mUC-non-EV, n = 103). Furthermore, we queried The Cancer Genome Atlas (TCGA) data sets (10,712 patients across 32 cancer types) for NECTIN4 CNVs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>NECTIN4 amplifications are frequent genomic events in muscle-invasive bladder cancer (TCGA bladder cancer data set: approximately 17%) and mUC (approximately 26% in our mUC cohorts). In mUC-EV, NECTIN4 amplification represents a stable genomic alteration during metastatic progression and associates with enhanced membranous NECTIN4 protein expression. Ninety-six percent (27 of 28) of patients with NECTIN4 amplifications demonstrated objective responses to EV compared with 32% (24 of 74) in the nonamplified subgroup ( P &lt; .001). In multivariable Cox analysis adjusted for age, sex, and Bellmunt risk factors, NECTIN4 amplifications led to a 92% risk reduction for death (hazard ratio, 0.08 [95% CI, 0.02 to 0.34]; P &lt; .001). In the mUC-non-EV, NECTIN4 amplifications were not associated with outcomes. TCGA Pan-Cancer analysis demonstrated that NECTIN4 amplifications occur frequently in other cancers, for example, in 5%-10% of breast and lung cancers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>NECTIN4 amplifications are genomic predictors of EV responses and long-term survival in patients with mUC.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.23.01983","type":"journal-article","created":{"date-parts":[[2024,4,24]],"date-time":"2024-04-24T16:02:43Z","timestamp":1713974563000},"page":"2446-2455","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":139,"title":["<i>NECTIN4<\/i>\n                    Amplification Is Frequent in Solid Tumors and Predicts Enfortumab Vedotin Response in Metastatic Urothelial Cancer"],"prefix":"10.1200","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3258-0586","authenticated-orcid":false,"given":"Niklas","family":"Kl\u00fcmper","sequence":"first","affiliation":[{"name":"Department of Urology and Pediatric Urology, University Hospital Bonn, Bonn, Germany"},{"name":"Institute of Experimental Oncology, University Medical Center Bonn (UKB), Bonn, Germany"},{"name":"Center for Integrated Oncology Aachen\/Bonn\/Cologne\/D\u00fcsseldorf (CIO-ABCD), Bonn, Germany"},{"name":"BRIDGE-Consortium Germany e.V., Mannheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-9612-1056","authenticated-orcid":false,"given":"Ngoc Khanh","family":"Tran","sequence":"additional","affiliation":[{"name":"Department of Urology and Pediatric Urology, University Hospital Bonn, Bonn, Germany"},{"name":"Institute of Experimental Oncology, University Medical Center Bonn (UKB), Bonn, Germany"},{"name":"Center for 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