AstraZeneca announced positive interim results from its VOLGA clinical trial, showing that its immunotherapy drug Imfinzi (durvalumab) significantly improved survival outcomes for patients with muscle-invasive bladder cancer (MIBC).
According to the company, the planned interim analysis demonstrated “statistically significant and clinically meaningful” improvements in both event-free survival (EFS) and overall survival (OS) when Imfinzi was combined with neoadjuvant enfortumab vedotin before surgery, compared with the current standard of care.
Muscle-invasive bladder cancer affects around one in four bladder cancer patients and occurs when tumors spread into the muscle wall of the bladder. Many patients are unable to receive cisplatin-based chemotherapy because of kidney impairment or other health complications, limiting available treatment options.
The current standard treatment for MIBC is radical cystectomy, a procedure involving complete removal of the bladder. However, recurrence rates remain high and long-term prognosis is often poor.
AstraZeneca also tested a second combination involving Imjudo (tremelimumab) alongside Imfinzi and enfortumab vedotin. The combination showed clinically meaningful improvement in event-free survival and a favorable trend in overall survival, although the OS data did not yet reach statistical significance at the interim stage.
Susan Galbraith, Executive Vice President of Oncology Hematology R&D at AstraZeneca, said the VOLGA trial marks the company’s third positive bladder cancer study following the NIAGARA and POTOMAC trials.
She added that the results help strengthen the foundation for Imfinzi as a core immunotherapy treatment in early-stage bladder cancer settings where the goal is long-term cure rather than disease management.
The positive findings further expand AstraZeneca’s oncology pipeline and reinforce the company’s growing position in cancer immunotherapy treatments.
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