VOLGA
What it tests: Perioperative durvalumab with or without tremelimumab plus neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer. Phase 3 results.
4Sight: VOLGA
All ESMO 2026 4Sights
In brief
Perioperative Durvalumab With or Without Tremelimumab Plus Neoadjuvant Enfortumab Vedotin in Muscle-Invasive Bladder Cancer: Results From the Phase 3 VOLGA Trial
Phase 3 (n=695): perioperative durvalumab ± tremelimumab + neoadjuvant enfortumab vedotin vs control (RC, then observation or approved adjuvant therapy) in cisplatin-ineligible MIBC. Interim analysis; median EFS follow-up 22.9 mo.
- D+EV: EFS HR 0.51 (0.38–0.67); OS HR 0.58 (0.40–0.83)
- D+T+EV: EFS HR 0.61 (0.47–0.80); OS did not meet significance
- pCR 45% (D+EV) vs 10% (control); grade 3/4 TRAEs 30% and 42%
- Both EFS primary endpoints met; perioperative durvalumab plus 3 cycles of neoadjuvant EV also significantly improved OS.
Thomas Powles
Alexandra Drakaki · Jeremy Teoh · Enrique Grande · Mario Fontes-Sousa · Camillo Porta · Esther Wu · Erik Goluboff · Svetlana Ho · Stephan Hois · Ashok Gupta · James Catto