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Pivotal trial of enfortumab vedotin in urothelial carcinoma after platinum and anti-programmed death 1/programmed death ligand 1 therapy

Journal of Clinical Oncology Oct 18, 2019

Rosenberg JE, O’Donnell PH, Balar AV, et al. - Researchers performed EV-201, a global, phase 2, single-arm study including patients with locally advanced or metastatic urothelial carcinoma who were previously treated with platinum chemotherapy and anti–PD-1/L1 therapy in order to determine the efficacy of enfortumab vedotin, an antibody–drug conjugate that targets Nectin-4, which is highly expressed in urothelial carcinoma. Enfortumab vedotin 1.25 mg/kg was administered intravenously on days 1, 8, and 15 of every 28-day cycle to 125 patients with metastatic urothelial carcinoma. During a median follow-up of 10.2 months (range, 0.5 to 16.5 months), they noted a confirmed objective response rate of 44% (95% CI, 35.1% to 53.2%), including 12% complete responses. Outcomes suggest that with a manageable and tolerable safety profile, enfortumab vedotin showed a clinically meaningful response rate in these patients.
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