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For patients who cannot have cisplatin, the ADC-immunotherapy pair around surgery cut the risk of recurrence or death by 60% and the risk of death by half.
EV-303, also KEYNOTE-905, trial NCT03924895 sponsored by Astellas, Pfizer and Merck and reported at ESMO 2025 and in the New England Journal of Medicine, showed that for patients with muscle-invasive bladder cancer who cannot have cisplatin, perioperative enfortumab vedotin plus pembrolizumab around cystectomy cut the risk of recurrence or death by sixty percent and the risk of death by half. It randomised 344 patients, met its primary event-free survival endpoint, improved overall survival and raised the pathologic complete response rate from under a tenth to more than half, the largest effect yet seen in a perioperative bladder trial, leading to FDA approval in November 2025. Whether responders can keep their bladders is the open question.
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.
344 enrolled.
Numbers not yet public.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survivalprimary | EV + pembrolizumab, perioperative | - | - | 0.4 (0.28 to 0.56) | - | link |
| Cystectomy alone | - | - | ||||
| Overall survival | EV + pembrolizumab | - | - | 0.5 (0.33 to 0.74) | - | - |
| Cystectomy alone | - | - | ||||
| Pathologic complete response | EV + pembrolizumab | - | 57.1% | - | - | - |
| Cystectomy alone | - | 8.6% |
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 + pembrolizumab across the bladder cancer continuum, Nectin-4, Enfortumab vedotin, Astellas.
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, Astellas, Antibody-drug conjugate (ADC), Pembrolizumab.
Shares Enfortumab vedotin, Astellas, Bladder & urothelial cancer, Antibody-drug conjugate (ADC).
Shares Bladder preservation for MIBC after perioperative EV + pembrolizumab complete response, Nectin-4, Enfortumab vedotin, Astellas.
Shares Nectin-4, Enfortumab vedotin, Bladder & urothelial cancer, Antibody-drug conjugate (ADC).