Pfizer, Astellas post late-stage trial win for Padcev with Merck’s Keytruda in bladder cancer

Pfizer (NYSE:PFE) and Astellas Pharma (OTCPK:ALPMF) announced on Tuesday that their jointly developed antibody-drug conjugate, Padcev, in combination with Merck’s (NYSE:MRK) PD-1 inhibitor, Keytruda, reached the main goals in a late-stage trial for certain patients with bladder cancer.

Citing interim data from their Phase 3 EV-303 clinical trial, the companies said that Padcev, also known as enfortumab vedotin, with Keytruda (pembrolizumab), led to a clinically meaningful and statistically significant improvement in the primary endpoint, the event-free survival (EFS).

Additionally, the drug combination also improved the patients’ overall survival (OS), meeting a key secondary endpoint of the study, also called KEYNOTE-905, with a clinically meaningful and statistically significant effect.

An open-label trial, EV-303, was designed to evaluate Padcev with Keytruda as a neoadjuvant and adjuvant (before and after surgery) option versus surgery alone for patients with muscle-invasive bladder cancer for whom cisplatin-based chemotherapy is not indicated.

In the study, Padcev in combination with Keytruda demonstrated tolerability profiles in line with their individual safety profiles, the companies stated.

Pfizer (NYSE:PFE) and Astellas (OTCPK:ALPMY) plan to discuss the results with global health authorities seeking potential regulatory submissions as the trial continues to evaluate its other secondary goals: EFS, OS, and pathologic complete response ((pCR)).