EV-303 / KEYNOTE-905
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.
EFS HR 0.40; OS HR 0.50; pCR 57.1% vs 8.6%. Presented ESMO 2025 (NEJM); FDA approval November 2025 for perioperative EV + pembrolizumab in cisplatin-ineligible MIBC. The largest effect size yet seen in a perioperative bladder trial.
- The treated group had about 60 percent lower chance of the event at any given time (hazard ratio 0.4).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- The treated group had about 50 percent lower chance of the event at any given time (hazard ratio 0.5).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 57.1 vs 8.6 out of 100 had no cancer left at surgery with EV + pembrolizumab compared with Cystectomy alone; 48.5 more per 100.
- Roughly one extra person helped for every 2 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Cisplatin-ineligible MIBC: perioperative enfortumab vedotin + pembrolizumab with cystectomy vs cystectomy alone. People in a different situation may not see the same effect.
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 participants enrolled.
Numbers not yet public.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survivalprimary | EV + pembrolizumab, perioperative | — | — | 0.4 (0.28–0.56) | — | link |
| Cystectomy alone | — | — | ||||
| Overall survival | EV + pembrolizumab | — | — | 0.5 (0.33–0.74) | — | — |
| Cystectomy alone | — | — | ||||
| Pathologic complete response | EV + pembrolizumab | — | 57.1% | — | — | — |
| Cystectomy alone | — | 8.6% |
Pages like this
not linked directly; found by shared links- TrialEV-304 / KEYNOTE-B15
Shares Enfortumab vedotin + pembrolizumab across the bladder cancer continuum, Bladder preservation for MIBC after perioperative EV + pembrolizumab complete response, Enfortumab vedotin, Bladder & urothelial cancer.
- TrialEV-302 / KEYNOTE-A39
Shares Enfortumab vedotin + pembrolizumab across the bladder cancer continuum, Nectin-4, Enfortumab vedotin, Bladder & urothelial cancer.
- PersonShilpa Gupta
Shares Enfortumab vedotin, Bladder & urothelial cancer, Pembrolizumab.
- ProductZelenectide pevedotin
Shares Nectin-4, Bladder & urothelial cancer.
- PersonJae Lyun Lee
Shares Enfortumab vedotin, Bladder & urothelial cancer, Pembrolizumab.
- TermWindow-of-opportunity trial
Shares Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative.
- CompanyAktis Oncology
Shares Nectin-4, Bladder & urothelial cancer.
- Key paperEV-302: enfortumab vedotin plus pembrolizumab replaces chemotherapy as first treatment for advanced bladder cancer
Shares Nectin-4, Enfortumab vedotin, Bladder & urothelial cancer, Pembrolizumab.