Pfizer (PFE) and Astellas Pharma (ALPMY) announced on Wednesday that their antibody drug conjugate Padcev, with Merck’s (MRK) anti-PD-1 therapy Keytruda, succeeded in a Phase 3 pivotal trial for certain patients with muscle-invasive bladder cancer (MIBC).
Citing topline data from the study, EV-304/KEYNOTE-B15, the duo noted that the Padcev regimen, when used both before and after surgery (as neoadjuvant and adjuvant therapy), led to a clinically meaningful and statistically significant improvement in patients’ event-free survival.
With its primary endpoint being the EFS, the ongoing open-label study is designed to evaluate Padcev plus Keytruda (pembrolizumab) versus neoadjuvant chemotherapy in patients with MIBC who are ineligible for cisplatin-based chemotherapy.
Padcev plus Keytruda also improved overall survival, the “gold standard” for measuring the clinical benefits of a cancer drug, thus achieving a key secondary endpoint in EV-304 with a clinically meaningful and statistically significant effect, the companies said.
The experimental therapy indicated a safety profile consistent with the established tolerability profile of the drug regimen, according to Pfizer (PFE) and Astellas (ALPMF), who added that they will discuss the trial data with global health officials in preparation for potential regulatory filings.