Pfizer (NYSE:PFE) and Astellas have announced positive topline results from the interim analysis of the Phase 3 EV-304 (KEYNOTE-B15) trial, evaluating the combination of PADCEV (enfortumab vedotin) and Keytruda (pembrolizumab) in cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC).
The trial, which compared the combination therapy to standard cisplatin-based neoadjuvant chemotherapy, met its primary endpoint, demonstrating clinically meaningful and statistically significant improvements in event-free survival (EFS).
Additionally, the trial showed a statistically significant improvement in overall survival (OS), a key secondary endpoint, as well as in pathologic complete response (pCR), further supporting the combination's potential in MIBC treatment.
Safety findings were consistent with the known safety profiles of both drugs.
The results are expected to be presented at an upcoming medical meeting, with discussions planned with global health authorities regarding potential regulatory filings for the combination treatment.