Patients with muscle-invasive bladder cancer who cannot receive cisplatin have had limited perioperative options. This trial randomized 344 participants to enfortumab vedotin plus pembrolizumab before and after surgery or to surgery alone. At two years, event-free survival was 74.7% versus 39.4%, and overall survival 79.7% versus 63.1%. Pathological complete response also differed markedly, but grade 3 or worse adverse events occurred in 71.3% of the combination group.
Key findings
- At two years, event-free survival was 74.7% versus 39.4% (HR 0.40; 95% CI 0.28-0.57), overall survival 79.7% versus 63.1% (HR 0.50; 95% CI 0.33-0.74), and pathological complete response 57.1% versus 8.6%. Grade 3 or worse adverse events occurred in 71.3% versus 45.9%; grade 3 or worse drug-related events occurred in 45.5% of the intervention group.
Why this matters globally
The magnitude of benefit in both event-free and overall survival could change practice for a population lacking cisplatin options. Real-world impact will depend on regulatory decisions, price, toxicity-management capacity and patient selection outside the trial.
Thai researcher contribution
Pongwut Danchaivijitr of Siriraj Hospital and Mahidol University is a coauthor, demonstrating Thai-center participation in an international trial network. The abstract does not report Thai enrollment or center-specific responsibilities.
Limitations to consider
The trial was open-label and tested a multi-agent regimen against surgery alone, so the contribution of each drug cannot be isolated. Median follow-up of 25.6 months limits long-term safety and late survival assessment. Generalization to cisplatin-eligible patients requires caution, and the trial was industry funded.