{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T12:19:36Z","timestamp":1780489176525,"version":"3.54.1"},"reference-count":42,"publisher":"Wiley","issue":"21","license":[{"start":{"date-parts":[[2024,11,12]],"date-time":"2024-11-12T00:00:00Z","timestamp":1731369600000},"content-version":"vor","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100020124","name":"Seagen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100020124","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004948","name":"Astellas Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004948","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Enfortumab vedotin, a fully human monoclonal antibody\u2013drug conjugate (ADC) directed to Nectin\u20104, prolonged overall survival (OS) versus standard chemotherapy in patients with previously treated locally advanced or metastatic urothelial carcinoma (mUC) previously receiving a programmed cell death protein 1\/ligand 1 (PD\u20101\/L1) inhibitor and platinum\u2010based chemotherapy in the pivotal, phase 3 EV\u2010301 clinical trial, supporting global approvals of enfortumab vedotin monotherapy. This bridging study was the first to evaluate enfortumab vedotin monotherapy in previously treated Chinese patients with locally advanced or mUC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      EV\u2010203 was a multicenter, open\u2010label, phase 2 study (NCT04995419) assessing efficacy, safety\/tolerability, pharmacokinetics (PK), and immunogenicity of enfortumab vedotin in 40 Chinese patients (PK analysis set,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200913) with previously treated locally advanced or mUC. Patients received enfortumab vedotin 1.25\u2009mg\/kg (Days 1, 8, and 15). Primary endpoints included confirmed objective response rate (ORR) by the independent review committee (IRC) and PK parameters of ADC, total antibody (TAb), and free monomethyl auristatin E (MMAE). Secondary endpoints included investigator\u2010assessed confirmed ORR; investigator\u2010\/IRC\u2010assessed duration of response (DOR), disease control rate (DCR), and progression\u2010free survival (PFS); OS; immunogenicity; and safety\/tolerability.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      As of May 13, 2022, the median follow\u2010up was 6.5\u2009months. Confirmed ORR was 37.5% (n\/\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200915\/40; 95% CI: 22.7%\u201354.2%) by IRC and 42.5% (n\/\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200917\/40; 95% CI: 27.0%\u201359.1%) by investigator assessment. By IRC, DCR was 72.5% (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200929), median DOR was not reached, and median PFS was 4.7\u2009months. Median OS was not reached. Endpoints assessed by investigators were consistent with IRC assessments. Two patients discontinued treatment for treatment\u2010related adverse events. No new safety signals were identified. ADC, TAb, and free MMAE were characterized in Chinese patients and consistent with previously characterized populations. The incidence of positive antitherapeutic antibodies postbaseline was 0%.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Enfortumab vedotin demonstrated meaningful clinical activity with a manageable safety profile in Chinese patients with previously treated locally advanced or mUC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      identifier: NCT04995419\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cam4.70368","type":"journal-article","created":{"date-parts":[[2024,11,12]],"date-time":"2024-11-12T08:13:55Z","timestamp":1731399235000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Phase 2 Trial of Enfortumab Vedotin in Patients With Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma in China"],"prefix":"10.1002","volume":"13","author":[{"given":"Siming","family":"Li","sequence":"first","affiliation":[{"name":"Department of Genitourinary Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education\/Beijing) Peking University Cancer Hospital &amp; Institute  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanxia","family":"Shi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine Sun Yat\u2010sen University Cancer Center  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haiying","family":"Dong","sequence":"additional","affiliation":[{"name":"Department of Urology Zhejiang Provincial People's Hospital  Hangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongqian","family":"Guo","sequence":"additional","affiliation":[{"name":"Department of Urology, Drum Tower Hospital Medical School of Nanjing University, Institute of Urology, Nanjing University  Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Xie","sequence":"additional","affiliation":[{"name":"Department of Urology, Hunan Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine Central South University  Hunan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhongquan","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Urology Huadong Hospital, Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoping","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology (Key Department of Jiangsu Medicine) Zhongda Hospital, Southeast University Medical School  Nanjing Jiangsu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Kim","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Bothell Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Zhang","sequence":"additional","affiliation":[{"name":"Astellas (China) Investment co., Ltd.  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