Padcev-Keytruda Combination Succeeds Again in Cisplatin-Eligible Muscle-Invasive Bladder Cancer

The Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) combination showed statistically significant and clinically meaningful improvements in event-free survival (primary endpoint), overall survival, and pathologic complete response rate in the perioperative setting for cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC), according to topline results from the KEYNOTE-B15/EV-304 Phase 3 trial announced December 17, 2025.12

The regimen was given before and after surgery, compared to neoadjuvant chemotherapy followed by surgery.1

This follows prior FDA approval of the combo for perioperative MIBC in chemo-ineligible patients; full results expected at a medical meeting like ASCO-GU in February 2026.1

Pfizer, Astellas, and Merck & Co. are the partners involved.1

Experts like Dr. Matthew Galsky highlight its potential to improve survival outcomes in high-risk patients.2

Sources:

1. https://www.oncologypipeline.com/apexonco/padcev-and-keytruda-prevail-again-early-bladder-cancer

2. https://www.merck.com/news/keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-significantly-improved-event-free-survival-overall-survival-and-pathologic-complete-response-rates-for-cisplatin-eligible-pa/