AstraZeneca's bladder cancer drug yields encouraging test results

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

The Cambridge-based pharmaceutical firm tested perioperative treatment, or treatment around the time of surgery, with imfinzi or durvalumab, combined with neoadjuvant or pre-surgery enfortumab vedotin.

This combination was linked to "statistically significant and clinically meaningful" improvements in event-free survival rates and "a favourable trend" for overall survival among patients with muscle-invasive bladder cancer, when compared with standard care.

Overall survival results in the Volga trial "were not statistically significant at this planned interim analysis and will be formally reassessed at a subsequent analysis," AstraZeneca noted.

Trial participants dosed with imfinzi were ineligible for or had declined cisplatin-based chemotherapy, while those in the comparator arm had a radical cystectomy, which is a bladder removal procedure, either with or without approved adjuvant treatment.

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.

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."​

AstraZeneca shares rose 0.4% to 13,818.00 on Thursday morning in London.

By Holly Munks, Alliance News reporter

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