AstraZeneca (LSE:AZN) reported perioperative Imfinzi (durvalumab) plus neoadjuvant enfortumab vedotin significantly improved event‑free survival and overall survival versus radical cystectomy in the VOLGA Phase III trial for patients with muscle‑invasive bladder cancer who were ineligible for or declined cisplatin.
A second experimental arm that added Imjudo (tremelimumab) to perioperative Imfinzi plus neoadjuvant enfortumab vedotin also showed a statistically significant improvement in event‑free survival and a favourable, but not statistically significant, trend for overall survival at this planned interim analysis.
"The VOLGA results show that perioperative durvalumab significantly extends event‑free survival and overall survival when combined with enfortumab vedotin, with a manageable safety profile," said Thomas Powles, International Coordinating Investigator for the trial.
VOLGA randomised 695 patients 1:1:1 across 182 centres in 25 countries to three arms: Arm 1 (Imfinzi+EV with perioperative Imjudo), Arm 2 (Imfinzi+EV), and Arm 3 (radical cystectomy with or without approved adjuvant therapy).
Safety and tolerability for Imfinzi with or without Imjudo plus enfortumab vedotin were consistent with the known profiles of the individual medicines and no new safety signals were identified.
AstraZeneca said the high‑level data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
