AstraZeneca announces results interim analysis of Volga Phase III trial

High-level results from a planned interim analysis of the Volga Phase III trial showed perioperative treatment with Imfinzi in combination with neoadjuvant enfortumab vedotin, EV, demonstrated statistically significant and clinically meaningful improvements in event-free survival, EFS, and overall survival, OS, in patients with muscle-invasive bladder cancer, MIBC, versus standard of care. Patients were ineligible for or had declined cisplatin-based chemotherapy. Patients in the comparator arm had a radical cystectomy with or without approved adjuvant treatment. Perioperative Imfinzi plus Imjudo in combination with neoadjuvant EV demonstrated a statistically significant and clinically meaningful improvement in EFS and a favourable trend for OS; however, the OS data were not statistically significant at this planned interim analysis and will be formally reassessed at a subsequent analysis. The safety and tolerability of Imfinzi with or without Imjudo plus EV was consistent with the known safety profiles of the individual medicines, with no new safety signals identified. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.