{"doi":"10.1200/jco.24.00646","title":"Phase II Trial of Enfortumab Vedotin in Patients With Previously Treated Advanced Head and Neck Cancer","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–directed 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 ≥3 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 ≥3 TRAEs; anemia and decreased neutrophil count occurred in ≥1 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>","journal":"Journal of Clinical Oncology","year":2025,"id":623122,"datarank":0.5050943744979712,"base_score":3.367295829986474,"endowment":3.367295829986474,"self_citation_contribution":0.5050943744979712,"citation_network_contribution":0.0,"self_endowment_contribution":0.5050943744979712,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":28,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":799782,"name":"Emrullah Yilmaz","orcid":"0000-0003-2308-713X","position":1,"is_corresponding":false},{"id":570226,"name":"Ari J. Rosenberg","orcid":"0000-0001-5908-0939","position":2,"is_corresponding":false},{"id":601036,"name":"Takao Fujisawa","orcid":"0000-0002-9196-9436","position":3,"is_corresponding":false},{"id":353966,"name":"Justine Y. Bruce","orcid":"0000-0002-5902-7430","position":4,"is_corresponding":false},{"id":477296,"name":"Changting Meng","orcid":"0000-0002-9438-5719","position":5,"is_corresponding":false},{"id":1277082,"name":"Michele Wozniak","orcid":null,"position":6,"is_corresponding":false},{"id":1610339,"name":"Yongyun Zhao","orcid":null,"position":7,"is_corresponding":false},{"id":1603345,"name":"Michael Mihm","orcid":null,"position":8,"is_corresponding":false},{"id":1610340,"name":"Jason Kaplan","orcid":"0000-0003-3085-7147","position":9,"is_corresponding":false},{"id":1610341,"name":"Seema Gorla","orcid":"0009-0006-5256-2189","position":10,"is_corresponding":false},{"id":1610342,"name":"Jessica L. Geiger","orcid":null,"position":11,"is_corresponding":false},{"id":376562,"name":"Paul Swiecicki","orcid":"0000-0003-2286-3555","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"citation_network_status":"fetched"},"created_at":"2026-08-03T22:26:58.469524Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}