AstraZeneca (NASDAQ: AZN) reported that its VOLGA Phase III trial met primary endpoints, showing statistically significant improvements in event-free survival and overall survival for patients with muscle-invasive bladder cancer.

The interim analysis evaluated perioperative treatment with Imfinzi (durvalumab) combined with neoadjuvant enfortumab vedotin versus standard of care in patients ineligible for or who declined cisplatin-based chemotherapy. The comparator group received radical cystectomy with or without approved adjuvant treatment.

A second treatment arm combining Imfinzi with Imjudo (tremelimumab) and neoadjuvant enfortumab vedotin demonstrated statistically significant improvement in event-free survival and a favorable trend for overall survival, though overall survival data did not reach statistical significance at this interim analysis.

Approximately 25% of bladder cancer patients have muscle-invasive disease, and up to 50% are ineligible for cisplatin-based chemotherapy due to impaired kidney function or other medical conditions. Standard treatment for these patients has been radical cystectomy alone, which carries high recurrence rates and poor prognosis.

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

Imfinzi is currently approved in over 40 countries for cisplatin-eligible muscle-invasive bladder cancer patients based on the NIAGARA Phase III trial. The drug is also under regulatory review in multiple jurisdictions for high-risk non-muscle-invasive bladder cancer following positive results from the POTOMAC Phase III trial.