PADCEV + Keytruda cuts risk of recurrence or death by nearly 50% in cisplatin-eligible muscle-invasive bladder cancer

CAR-T Digest - August 2020

Weekly Digest - March 2026

27 February 2026: PADCEV + Keytruda cuts risk of recurrence or death by nearly 50% in cisplatin-eligible muscle-invasive bladder cancer

Pfizer and Astellas Pharma reported strong Phase 3 results for a perioperative combination of PADCEV (Enfortumab vedotin) and Keytruda (pembrolizumab), demonstrating that the regimen significantly improved outcomes for patients with muscle-invasive bladder cancer in the EV-304/KEYNOTE-B15 trial
Building on this, the trial showed a major clinical benefit compared with standard chemotherapy, as the PADCEV–Keytruda combination reduced the risk of tumor recurrence, progression, or death by 47%, with nearly 79.4% of patients remaining event-free at two years, versus 66.2% for patients treated with the conventional gemcitabine-cisplatin regimen
The survival advantage extended beyond disease control, with the combination also achieving a 35% reduction in the risk of death and delivering a markedly higher pathological complete response rate of 55.8%, meaning that more than half of treated patients had no detectable disease at the time of surgery
These outcomes reinforce growing evidence supporting the regimen’s potential to reshape treatment approaches, especially as the combination represents the first platinum-free perioperative therapy to significantly improve both event-free survival and overall survival, suggesting a possible shift away from platinum-based chemotherapy in this setting
Encouraged by these findings, the companies plan to discuss the data with global regulators, as the results presented at the ASCO Genitourinary Cancers Symposium could pave the way for new approvals and position the PADCEV plus Keytruda regimen as a future standard of care for muscle-invasive bladder cancer, regardless of cisplatin eligibility