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The trial that could replace chemotherapy before bladder removal in fit patients with an ADC plus immunotherapy.
EV-304, also KEYNOTE-B15, trial NCT04700124 sponsored by Merck, Astellas and Pfizer and reported from December 2025, is the trial that could replace chemotherapy before bladder removal in fit patients with an antibody-drug conjugate plus immunotherapy. It randomised 808 cisplatin-eligible patients with muscle-invasive bladder cancer to perioperative enfortumab vedotin plus pembrolizumab or neoadjuvant gemcitabine and cisplatin, both with cystectomy, and showed significant improvements in event-free survival, overall survival and pathologic complete response, published in the New England Journal of Medicine with a filing expected in 2026. Whether the pair becomes the default across the whole bladder cancer pathway is the question it and EV-302 together pose.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
808 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival at 2 yearsprimary | Perioperative enfortumab vedotin + pembrolizumab | 405 | 79.4% | 0.53 (0.41 to 0.7) | <0.001 | link |
| Neoadjuvant cisplatin-gemcitabine | 403 | 66.2% | ||||
| Overall survival at 2 years | Perioperative enfortumab vedotin + pembrolizumab | - | 86.9% | 0.65 (0.48 to 0.89) | 0.006 | link |
| Neoadjuvant cisplatin-gemcitabine | - | 81.3% | ||||
| Pathological complete response | Perioperative enfortumab vedotin + pembrolizumab | - | 55.8% | - | <0.001 | link |
| Neoadjuvant cisplatin-gemcitabine | - | 32.5% |
Shares Enfortumab vedotin + pembrolizumab across the bladder cancer continuum, Bladder preservation for MIBC after perioperative EV + pembrolizumab complete response, Enfortumab vedotin, Astellas.
Shares Enfortumab vedotin, Astellas, Bladder & urothelial cancer, Antibody-drug conjugate (ADC).
Shares Enfortumab vedotin, Astellas, Antibody-drug conjugate (ADC), Pembrolizumab.
Shares Enfortumab vedotin, Astellas, Bladder & urothelial cancer, Antibody-drug conjugate (ADC).
Shares Enfortumab vedotin, Astellas, Bladder & urothelial cancer, Antibody-drug conjugate (ADC).
Shares Enfortumab vedotin + pembrolizumab across the bladder cancer continuum, Enfortumab vedotin, Astellas, Bladder & urothelial cancer.
Shares Enfortumab vedotin, Astellas, Pembrolizumab.
Shares Enfortumab vedotin, Bladder & urothelial cancer, Antibody-drug conjugate (ADC), Pembrolizumab.