Pfizer, Astellas Pharma announce topline results from EV-303 clinical trial

Pfizer (PFE) and Astellas Pharma (ALPMY) announced topline results from the Phase 3 EV-303 clinical trial. The EV-303 study is evaluating Padcev, a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda, a PD-1 inhibitor, as neoadjuvant and adjuvant treatment versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer who are not eligible for or declined cisplatin-based chemotherapy. At the first interim efficacy analysis, the trial demonstrated a clinically meaningful and statistically significant improvement in event-free survival, the study’s primary endpoint, and overall survival, a key secondary endpoint, with neoadjuvant and adjuvant Padcev plus Keytruda versus surgery alone. An additional secondary endpoint of pathologic complete response rate was also met.