OnCo
trialsTrialPositive

EV-304 / KEYNOTE-B15

The trial that could replace chemotherapy before bladder removal in fit patients with an ADC plus immunotherapy.

Topline December 2025: statistically significant improvements in EFS, OS, and pCR versus neoadjuvant chemotherapy; full data and regulatory filing expected in 2026. Together with EV-303 and EV-302, it would make EV + pembrolizumab the default across the bladder cancer continuum.

Setting
Cisplatin-eligible MIBC: perioperative enfortumab vedotin + pembrolizumab vs neoadjuvant gemcitabine-cisplatin, both with cystectomy
Phase
Phase 3
Sponsor
Merck / Astellas / Pfizer
Registry
Headline result
EFS, OS, and pCR significantly improved (topline; details pending).
Reported
2025
Replication
Second positive perioperative EV + pembrolizumab phase 3 after EV-303.

Connected

5top