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Nearly doubled survival in advanced bladder cancer, ending 40 years of platinum chemotherapy as the standard.
EV-302, also KEYNOTE-A39, trial NCT04223856 sponsored by Astellas, Pfizer and Merck and published in the New England Journal of Medicine in 2023, nearly doubled survival in first-line advanced urothelial cancer, ending forty years of platinum chemotherapy as the standard. It randomised 886 patients to enfortumab vedotin plus pembrolizumab or platinum with gemcitabine, met both primary endpoints of progression-free and overall survival with very large effects and a much higher response rate, and the extended follow-up in 2025 maintained the survival advantage. It is the template for ADC plus immunotherapy combinations now copied in breast and lung cancer, and how far that template travels 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.
886 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 to 0.54) | <0.001 | link |
| Platinum + gemcitabine | 444 | 6.3 months | ||||
| Overall survivalprimary | Enfortumab vedotin + pembrolizumab | - | 31.5 months | 0.47 (0.38 to 0.58) | <0.001 | link |
| Platinum + gemcitabine | - | 16.1 months | ||||
| Objective response rate | Enfortumab vedotin + pembrolizumab | - | 67.7% | - | - | link |
| Platinum + gemcitabine | - | 44.4% |
Shares Enfortumab vedotin + pembrolizumab across the bladder cancer continuum, Nectin-4, Enfortumab vedotin, Astellas.
Shares Enfortumab vedotin + pembrolizumab across the bladder cancer continuum, Enfortumab vedotin, Astellas, Bladder & urothelial cancer.
Shares Enfortumab vedotin, Astellas, Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer.
Shares Enfortumab vedotin, Astellas, Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer.
Shares Enfortumab vedotin, Astellas, Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer.
Shares Enfortumab vedotin, Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Antibody-drug conjugate (ADC).
Shares Enfortumab vedotin, Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Antibody-drug conjugate (ADC).
Shares Enfortumab vedotin, Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer, Antibody-drug conjugate (ADC).