{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T08:54:04Z","timestamp":1791536044672,"version":"4.3.4"},"reference-count":27,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"5","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2025,2,10]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>\n                      Despite advances in immunotherapy, unresectable recurrent\/metastatic head and neck cancer (HNC) carries a poor prognosis, and effective treatments are needed. As nectin-4 is widely expressed in HNC, enfortumab vedotin (EV), a nectin-4\u2013directed antibody-drug conjugate, was explored in HNC in EV-202 (ClinicalTrials.gov identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT04225117\">NCT04225117<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>This open-label, multicohort, phase II study evaluated intravenous EV 1.25 mg\/kg on days 1, 8, and 15 of each 28-day cycle. In the HNC cohort, eligible patients had recurrent\/metastatic HNC and had received platinum-based therapy for locally advanced\/metastatic disease and a PD-1\/PD-L1 inhibitor. The primary end point was investigator-assessed confirmed objective response rate (ORR) per RECIST version 1.1. Secondary end points were investigator-assessed duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS); overall survival (OS); and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>The primary analysis included 46 patients; all received EV (median follow-up, 9.3 months). Most patients (52.2%) had \u22653 previous lines of systemic therapy in the metastatic setting. Confirmed ORR was 23.9%, DCR was 56.5%, and median DOR was not reached (median DOR was 9.4 months at a later data cutoff [median follow-up, 11.3 months]). Median PFS and OS were 3.9 and 6.0 months, respectively. Treatment-related adverse events (TRAEs) occurring in &gt;20% of patients were alopecia (28.3%), fatigue (26.1%), and peripheral sensory neuropathy (23.9%). Sixteen patients (34.8%) experienced grade \u22653 TRAEs; anemia and decreased neutrophil count occurred in \u22651 patient (both n = 2; 4.3%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>EV demonstrated antitumor activity in heavily pretreated HNC. Safety was consistent with the known safety profile of EV; no new safety signals were identified. These data support further evaluation of EV for advanced HNC not amenable to definitive local therapy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.24.00646","type":"journal-article","created":{"date-parts":[[2024,10,31]],"date-time":"2024-10-31T16:00:36Z","timestamp":1730390436000},"page":"578-588","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":30,"title":["Phase II Trial of Enfortumab Vedotin in Patients With Previously Treated Advanced Head and Neck Cancer"],"prefix":"10.1200","volume":"43","clinical-trial-number":[{"clinical-trial-number":"nct04225117","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2286-3555","authenticated-orcid":true,"given":"Paul L.","family":"Swiecicki","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, Division of Hematology\/Oncology, University of Michigan Rogel Cancer Center, Ann Arbor, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2308-713X","authenticated-orcid":true,"given":"Emrullah","family":"Yilmaz","sequence":"additional","affiliation":[{"name":"Department of Hematology and Medical Oncology, Taussig Cancer Center, Cleveland Clinic, Cleveland, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5908-0939","authenticated-orcid":true,"given":"Ari Joseph","family":"Rosenberg","sequence":"additional","affiliation":[{"name":"Department of Medicine, Section of Hematology\/Oncology, University of Chicago, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-3438-5757","authenticated-orcid":true,"given":"Takao","family":"Fujisawa","sequence":"additional","affiliation":[{"name":"Head and Neck Medical Oncology, National Cancer Center Hospital East, Chiba, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5902-7430","authenticated-orcid":true,"given":"Justine Yang","family":"Bruce","sequence":"additional","affiliation":[{"name":"University of Wisconsin Carbone Cancer Center, Madison, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Changting","family":"Meng","sequence":"additional","affiliation":[{"name":"Pfizer, Bothell, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Wozniak","sequence":"additional","affiliation":[{"name":"Astellas Pharma, Inc, Northbrook, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongyun","family":"Zhao","sequence":"additional","affiliation":[{"name":"Astellas Pharma, Inc, Northbrook, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Mihm","sequence":"additional","affiliation":[{"name":"Astellas Pharma, Inc, Northbrook, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3085-7147","authenticated-orcid":false,"given":"Jason","family":"Kaplan","sequence":"additional","affiliation":[{"name":"Astellas Pharma, Inc, Northbrook, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-5256-2189","authenticated-orcid":true,"given":"Seema","family":"Gorla","sequence":"additional","affiliation":[{"name":"Astellas Pharma, Inc, Northbrook, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica L.","family":"Geiger","sequence":"additional","affiliation":[{"name":"Department of Hematology and Medical Oncology, Taussig Cancer Center, Cleveland Clinic, Cleveland, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"e_1_3_9_2_2","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21834"},{"key":"e_1_3_9_3_2","unstructured":"Global Cancer Observatory: Global Cancer 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Leiden the Netherlands Astellas Pharma Europe 2024"},{"key":"e_1_3_9_23_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12094-020-02533-1"},{"key":"e_1_3_9_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)31999-8"},{"key":"e_1_3_9_25_2","doi-asserted-by":"publisher","DOI":"10.1186\/s40425-019-0578-0"},{"key":"e_1_3_9_26_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.19.01140"},{"key":"e_1_3_9_27_2","first-page":"A1231","article-title":"Enfortumab vedotin induces immunogenic cell death, elicits antitumor immune memory, and shows enhanced preclinical activity in combination with immune checkpoint inhibitors","volume":"10","author":"Olson D","year":"2022","unstructured":"Olson D, Younan P, Liu B, et al: Enfortumab vedotin induces immunogenic cell death, elicits antitumor immune memory, and shows enhanced preclinical activity in combination with immune checkpoint inhibitors. J Immunother Cancer 10:A1231, 2022 (suppl 2; abstr 1187)","journal-title":"J Immunother Cancer"},{"key":"e_1_3_9_28_2","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djn011"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.24.00646","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,5]],"date-time":"2025-02-05T17:59:50Z","timestamp":1738778390000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.24.00646"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,10]]},"references-count":27,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,2,10]]}},"alternative-id":["10.1200\/JCO.24.00646"],"URL":"https:\/\/doi.org\/10.1200\/jco.24.00646","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,10]]},"assertion":[{"value":"2024-03-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-07-31","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-09-26","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-10-31","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}