Pembrolizumab (Keytruda) and enfortumab vedotin (Padcev) significantly reduce the risk of recurrence and death in patients with muscle-invasive bladder cancer (MIBC), Pfizer shared in a recent press release.
Findings were based on the ongoing Phase 3 EV-304 trial, which enrolled individuals with MIBC who were eligible for cisplatin-based chemotherapy. Participants received either pembrolizumab plus enfortumab vedotin or the standard of care, which consists of gemcitabine and cisplatin.
Individuals who received the combination therapy both before and after surgery experienced a 47% lower risk of death, progression or recurrence compared with individuals receiving the standard of care.
After two years, 79.4% of participants in the treatment arm and 66.2% of those in the standard of care arm remained event-free. Furthermore, 55.8% of treated patients demonstrated a complete pathological response by the time of surgery. Findings were consistent across all patients, regardless of age, gender, geographic location, cancer stage and programmed death-ligand 1 (PD-L1) status. The investigators identified no new safety concerns.
Read more about bladder cancer therapies
These findings build upon the Phase 3 EV-303 study, which reported significant benefits from the combination therapy in patients with MIBC who are cisplatin-ineligible.
“These compelling data, reinforced by the unprecedented EV‑303 results, suggest a transformative opportunity to establish [enfortumab vedotin] plus pembrolizumab as the next standard of care if approved, and provide a meaningful step forward for patients and their families,” said Jeff Legos, chief oncology officer at Pfizer.
The U.S. Food and Drug Administration approved pembrolizumab plus enfortumab vedotin in November 2025 for individuals with MIBC who are not eligible for treatment with cisplatin.
Pfizer plans to enter into conversations with health authorities to discuss future regulatory filings.
Sign up here to get the latest news, perspectives, and information about bladder cancer sent directly to your inbox. Registration is free and only takes a minute.