Astellas, Pfizer report Padcev trial meets primary and secondary endpoints

Astellas Pharma (ALPMY) and Pfizer (PFE) announced topline results from an interim analysis of the Phase 3 EV-304 clinical trial for Padcev, a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda, a PD-1 inhibitor. This study is evaluating the combination as neoadjuvant and adjuvant treatment versus standard of care neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy. The trial met its primary endpoint, demonstrating clinically meaningful and statistically significant improvements in event-free survival, and overall survival, a key secondary endpoint. An additional secondary endpoint of pathologic complete response rate for neoadjuvant Padcev plus pembrolizumab versus neoadjuvant chemotherapy was also met, and a clinically meaningful and statistically significant improvement was observed. The safety profile for Padcev plus pembrolizumab was consistent with the known profile of the treatment regimen.