CORRECT: AstraZeneca bladder cancer trial yields encouraging results

(Correction clarifies that the phase III Volga trial was conducted across three arms and provides the findings for arms 1 and 2 versus the comparator arm)

(Alliance News) - AstraZeneca PLC on Thursday posted positive trial results for its bladder cancer treatment Imfinzi.

The phase III Volga trial evaluated perioperative Imfinzi with or without Imjudo in combination with neoadjuvant enfortumab vedotin as treatment for patients with muscle-invasive bladder cancer undergoing radical cystectomy who are not eligible for or have declined cisplatin.

In Arm 1, the Cambridge-based pharmaceutical firm evaluated perioperative Imfinzi, perioperative Imjudo and neoadjuvant enfortumab vedotin.

Data showed a statistically significant and clinically meaningful improvement in event-free survival and a favourable trend in overall survival versus the comparator arm, Arm 3, which included patients treated with radical cystectomy with or without approved adjuvant therapy.

However, the OS comparison between Arm 1 and Arm 3 was not statistically significant at this planned interim analysis. AstraZeneca said OS will be formally reassessed at a subsequent analysis.

Arm 2 evaluated perioperative Imfinzi with neoadjuvant enfortumab vedotin. Data showed statistically significant and clinically meaningful improvements in both event-free survival and overall survival versus the comparator arm.

Thomas Powles of Barts Cancer Centre, the coordinating investigator for the Volga trial, noted: "Up to half of patients with muscle-invasive bladder cancer are not eligible for cisplatin and face high rates of disease recurrence, even after having their bladder removed, leaving a significant need for new effective and well-tolerated treatments."

Susan Galbraith, executive vice president of Oncology Haematology R&D at AstraZeneca added: "Together with Niagara and Potomac, Volga is our third positive readout in bladder cancer, setting a strong foundation for Imfinzi as the immunotherapy backbone in this early-stage, curative-intent setting."​

No new safety signals were reported.

Imfinzi is already approved in about 40 countries for patients with cisplatin-eligible muscle-invasive bladder cancer based on the results of AstraZeneca's Niagara trial. When combined with Bacillus Calmette-Guerin therapy in the Potomac trial, imfinzi met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer. It is currently under review in the US, EU and Japan, alongside being tested in locally advanced or metastatic disease.

AstraZeneca shares closed up 0.1% at 13,774.00 pence on Thursday in London.

By Holly Munks, Alliance News reporter

Copyright 2026 Alliance News Ltd. All Rights Reserved.

Astrazeneca