Enfortumab vedotin and pembrolizumab improves EFS, OS, and pCR in muscle-invasive bladder cancer

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Published: 6 Mar 2026
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Dr Matthew Galsky - Icahn School of Medicine at Mount Sinai, New York, USA

Dr Matthew Galsky speaks to ecancer about results from the phase 3 KEYNOTE-B15/EV-304 trial.

The results show that perioperative enfortumab vedotin plus pembrolizumab significantly improves outcomes in patients with muscle-invasive bladder cancer (MIBC) eligible for cisplatin-based chemotherapy.

Compared with standard neoadjuvant gemcitabine plus cisplatin, the combination achieved higher pathologic complete response rates (55.8% vs 32.5%) and significantly improved event-free survival (HR 0.53) and overall survival (HR 0.65).

The safety profile was consistent with previous experience. These findings support enfortumab vedotin plus pembrolizumab as a promising perioperative treatment strategy for MIBC.