{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T14:43:43Z","timestamp":1779374623613,"version":"3.53.1"},"reference-count":25,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2020,11,6]],"date-time":"2020-11-06T00:00:00Z","timestamp":1604620800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Tislelizumab, an anti\u2010programmed death protein\u20101 (PD\u20101) monoclonal antibody, was engineered to minimize binding to the Fc\u03b3R on macrophages to abrogate antibody\u2010dependent phagocytosis, a mechanism of T\u2010cell clearance and potential resistance to anti\u2010PD\u20101 therapy. This single\u2010arm phase 2 trial (NCT04004221\/CTR20170071) assessed the safety, tolerability, and efficacy of tislelizumab in patients with PD\u2010L1\u2010positive urothelial carcinoma who progressed during\/following platinum\u2010containing therapy and had no prior PD\u2010(L)1 inhibitor treatment. Patients were considered PD\u2010L1 positive if\u00a0\u2265\u00a025% of tumor\/immune cells expressed PD\u2010L1 when using the VENTANA\u2122 PD\u2010L1 (SP263) assay. The primary endpoint was objective response rate by independent review committee. As of September 16, 2019, 113 patients had a median study follow\u2010up time of 9.4\u00a0mo. Most patients (76%) had visceral metastases, including 24% with liver and 23% with bone metastases. Among 104 efficacy\u2010evaluable patients, confirmed objective response rate was 24% (95% confidence interval, 16, 33), including 10 complete and 15 partial responses. Median duration of response was not reached. Among 25 responders, 17\/25 (68%) had ongoing responses. Median progression\u2010free survival and overall survival times were 2.1 and 9.8\u00a0mo, respectively. The most common treatment\u2010related adverse events were anemia (27%) and pyrexia (19%). Anemia (7%) and hyponatremia (5%) were the only grade 3\u20104 treatment\u2010related adverse events and occurred in\u00a0\u2265\u00a05% of patients. Three investigator\u2010assessed deaths were considered to be possibly related to study treatment (hepatic failure, n\u00a0=\u00a02; respiratory arrest, n\u00a0=\u00a01). Tislelizumab demonstrated meaningful clinical benefits in patients with previously treated locally advanced or metastatic PD\u2010L1\u2010positive urothelial carcinoma and had a manageable safety profile.<\/jats:p>","DOI":"10.1111\/cas.14681","type":"journal-article","created":{"date-parts":[[2020,10,13]],"date-time":"2020-10-13T02:07:02Z","timestamp":1602554822000},"page":"305-313","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":95,"title":["Tislelizumab in Asian patients with previously treated locally advanced or metastatic urothelial carcinoma"],"prefix":"10.1111","volume":"112","author":[{"given":"Dingwei","family":"Ye","sequence":"first","affiliation":[{"name":"Department of Urology Fudan University Shanghai Cancer Center Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiyan","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology West China Hospital 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