– Trial Stopped Early Due to Positive Results at Planned Interim Analysis –
– Data Intended to Support Global Registrations and Convert Accelerated to Regular Approval in U.S.
San Francisco, CA (UroToday.com) — Astellas Pharma Inc. and Seattle Genetics, Inc. announced that a phase 3 trial of PADCEV® (enfortumab vedotin-ejfv) met its primary endpoint of overall survival compared to chemotherapy. The results were reviewed by an independent Data Monitoring Committee following a planned interim analysis. The global EV-301 clinical trial compared PADCEV to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.