Padcev-Keytruda Combination Shows Strong Positive Data in Cisplatin-Eligible Muscle-Invasive Bladder Cancer

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The Phase 3 KEYNOTE-B15/EV-304 trial demonstrated that KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin) reduced the risk of event-free survival (EFS) events by 47% and the risk of death by 35% compared to neoadjuvant chemotherapy in cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC) when given before and after surgery.12

Statistically significant improvements in overall survival and pathological complete response were observed, with over half of patients showing no detectable disease at surgery.2

This builds on prior Phase 3 trials like KEYNOTE-905 and KEYNOTE-A39, showing OS benefits across bladder cancer stages, potentially establishing a new standard of care.12

Announced by Merck, Pfizer, and Astellas; results to be discussed with health authorities for regulatory filings.123

Sources:

1. https://www.merck.com/news/keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-reduced-risk-of-event-free-survival-events-by-47-and-risk-of-death-by-35-for-cisplatin-eligible-patients-with-muscle-invasive/

2. https://www.pfizer.com/news/press-release/press-release-detail/padcevtm-keytrudar-cuts-risk-recurrence-or-death-nearly-50

3. https://www.finanznachrichten.de/nachrichten-2026-02/67817104-pfizer-astellas-pharma-share-positive-data-from-bladder-cancer-trial-020.htm