(RTTNews) – Astellas Pharma Inc. and Pfizer Inc. announced positive topline results from the Phase 3 EV-304 clinical trial (KEYNOTE-B15), evaluating PADCEV (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor. The study assessed the combination as both neoadjuvant and adjuvant treatment—before and after surgery—compared to standard cisplatin-based chemotherapy in patients with muscle-invasive bladder cancer (MIBC).
The trial successfully met its primary endpoint, demonstrating clinically meaningful and statistically significant improvements in event-free survival (EFS). It also achieved a key secondary endpoint, sh