
On Tuesday, Merck & Co. Inc. (NYSE:MRK) released topline results from the Phase 3 KEYNOTE-905 trial (also known as EV-303) in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.
In this study, Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv), given before and after surgery (radical cystectomy), demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), the study’s primary endpoint, as well as overall survival (OS) and pathologic complete response (pCR) rate, key secondary endpoints, compared to surgery (radical cystectomy) alone.