Astellas, Pfizer announces results from Phase 3 EV-303 trial for PADCEV

Astellas Pharma (ALPMY) and Pfizer (PFE) announced positive results from the Phase 3 EV-303 clinical trial for PADCEV, a Nectin-4 directed antibody-drug conjugate, in combination with KEYTRUDA, a PD-1 inhibitor. The study evaluated the combination in patients with muscle-invasive bladder cancer, MIBC, who are ineligible for or declined cisplatin-based chemotherapy. PADCEV plus KEYTRUDA significantly improved event-free survival, EFS, and overall survival, OS, when used as a neoadjuvant and adjuvant treatment versus the current standard of care-surgery alone. Results from the EV-303 trial will be presented today in a Presidential Symposium at the 2025 European Society of Medical Oncology, ESMO, Congress in Berlin, Germany. At the first interim efficacy analysis, results from the primary endpoint of EFS showed a 60% reduction in the risk of tumor recurrence, progression or death for patients treated with neoadjuvant and adjuvant PADCEV plus KEYTRUDA as compared to surgery alone. The estimated median EFS has not yet been reached for the combination arm versus 15.7 months for the surgery alone arm. Results from the key secondary endpoint of OS showed a 50% reduction in the risk of death for neoadjuvant and adjuvant PADCEV plus KEYTRUDA as compared to surgery alone (.