EV-302 / KEYNOTE-A39
Nearly doubled survival in advanced bladder cancer, ending 40 years of platinum chemotherapy as the standard.
OS 31.5 vs 16.1 months (HR 0.47); PFS HR 0.45. The template for ADC + checkpoint inhibitor combinations now being copied in breast (ASCENT-04) and lung cancer.
- Median 12.5 vs 6.3 months with Enfortumab vedotin + pembrolizumab compared with Platinum + gemcitabine; about 6.2 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 55 percent lower chance of the event at any given time (hazard ratio 0.45, likely range 0.38 to 0.54).
- 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.
- Median 31.5 vs 16.1 months with Enfortumab vedotin + pembrolizumab compared with Platinum + gemcitabine; about 15.4 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 53 percent lower chance of the event at any given time (hazard ratio 0.47, likely range 0.38 to 0.58).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 67.7 vs 44.4 out of 100 had their tumour shrink with Enfortumab vedotin + pembrolizumab compared with Platinum + gemcitabine; 23.3 more per 100.
- Roughly one extra person helped for every 4 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: First-line advanced urothelial cancer: enfortumab vedotin + pembrolizumab vs platinum chemotherapy. 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.
886 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BICR)primary | Enfortumab vedotin + pembrolizumab | 442 | 12.5 months | 0.45 (0.38–0.54) | <0.001 | link |
| Platinum + gemcitabine | 444 | 6.3 months | ||||
| Overall survivalprimary | Enfortumab vedotin + pembrolizumab | — | 31.5 months | 0.47 (0.38–0.58) | <0.001 | link |
| Platinum + gemcitabine | — | 16.1 months | ||||
| Objective response rate | Enfortumab vedotin + pembrolizumab | — | 67.7% | — | — | link |
| Platinum + gemcitabine | — | 44.4% |
Pages like this
not linked directly; found by shared links- TrialEV-303 / KEYNOTE-905
Shares Enfortumab vedotin + pembrolizumab across the bladder cancer continuum, Nectin-4, Enfortumab vedotin, Bladder & urothelial cancer.
- TrialEV-304 / KEYNOTE-B15
Shares Enfortumab vedotin + pembrolizumab across the bladder cancer continuum, Enfortumab vedotin, Bladder & urothelial cancer, Pembrolizumab.
- PersonShilpa Gupta
Shares EV-302: enfortumab vedotin plus pembrolizumab replaces chemotherapy as first treatment for advanced bladder cancer, Enfortumab vedotin, Bladder & urothelial cancer, Pembrolizumab.
- TrialASCENT-04 / KEYNOTE-D19
Shares ADC + checkpoint inhibitor, ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs, Pembrolizumab.
- ProductAK146D1
Shares Nectin-4, ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs, Bladder & urothelial cancer.
- CompanyAstellas
Shares EV-302: enfortumab vedotin plus pembrolizumab replaces chemotherapy as first treatment for advanced bladder cancer, Enfortumab vedotin, Bladder & urothelial cancer.
- IdeaBladder preservation for MIBC after perioperative EV + pembrolizumab complete response
Shares Enfortumab vedotin, Bladder & urothelial cancer, Pembrolizumab.
- ProductZelenectide pevedotin
Shares Nectin-4, Bladder & urothelial cancer.