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EV-201: Results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors

Journal of Clinical Oncology Jun 13, 2019

Petrylak DP, et al. – In this report, the researchers presented preliminary data from Cohort 1 of EV-201—a pivotal, single-arm, two-cohort study—that included patients with locally advanced or metastatic urothelial cancer (la/mUC) with prior checkpoint inhibitor (CPI) and platinum-containing chemotherapy (Cohort 1) or a CPI and no prior chemotherapy (Cohort 2) who were treated with enfortumab vedotin (EV; an antibody-drug conjugate targeting Nectin-4, which is highly expressed in UC). Patients were given 1.25 mg/kg EV on Days 1, 8, and 15 of each 28-day cycle. The investigators noted a clinically meaningful ORR (the reported ORR was consistent with the phase 1 trial) in patients with la/mUC and prior platinum and CPI, including liver metastases pts, where there is a high unmet requirement. In these patients, EV demonstrated good tolerability and a manageable safety profile.

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