Dr Vulsteke talks to ecancer at ESMO 2025 about data he presented from the phase 3 KEYNOTE-905/EV-303 trial.

This evaluated perioperative enfortumab vedotin (EV) plus pembrolizumab (pembro) versus surgery alone in 344 patients with cisplatin-ineligible or cisplatin-declining muscle-invasive bladder cancer (MIBC).

At a median follow-up of 25.6 months, EV plus pembro significantly improved event-free survival (median not reached vs 15.7 months; HR 0.40; one-sided P<.0001 (boundary 0.0097)), overall survival (HR 0.50; one-sided P<.0002 (boundary 0.00488), and pathological complete response rate (57.1% vs 8.6%; one-sided P<.000001 (boundary 0.00025)). Grade ≥3 adverse events occurred in 71.3% vs 45.9% of patients, mainly skin reactions.

Dr Vulsteke notes that these results establish enfortumab vedotin plus pembrolizumab as the first perioperative regimen to significantly improve outcomes in cisplatin-ineligible MIBC, supporting its potential as a new standard of care.