Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (NYSE:AZN) reported on Thursday that interim Phase III VOLGA trial results showed that perioperative Imfinzi combined with neoadjuvant enfortumab vedotin (EV) delivered statistically significant and clinically meaningful improvements in event-free survival and overall survival in patients with muscle-invasive bladder cancer (MIBC).

The study involved patients who were ineligible for or declined cisplatin-based chemotherapy.

A separate treatment arm combining perioperative Imfinzi, Imjudo and neoadjuvant EV achieved a statistically significant improvement in event-free survival and showed a favourable overall survival trend, although the overall survival data did not reach statistical significance at the interim analysis. Patients in the comparator group underwent radical cystectomy with or without approved adjuvant treatment.

AstraZeneca said the safety profile of the combinations was consistent with the known profiles of the individual medicines, with no new safety signals identified. The company plans to present the data at an upcoming medical meeting and submit the results to global regulatory authorities.

Imfinzi is currently approved in more than 40 countries for cisplatin-eligible MIBC based on the NIAGARA Phase III trial. The therapy is also under regulatory review in several markets for high-risk non-muscle-invasive bladder cancer following positive Phase III POTOMAC trial results.