WILMINGTON, DE — AstraZeneca (LSE/STO/NYSE: AZN) reported positive Phase III trial results showing its immunotherapy IMFINZI combined with enfortumab vedotin improved survival outcomes for certain muscle-invasive bladder cancer patients unable or unwilling to receive cisplatin chemotherapy, expanding the company’s push to establish the drug as a foundational treatment in earlier-stage bladder cancer.
Results from the VOLGA Phase III trial showed the perioperative regimen significantly improved event-free survival and overall survival compared with standard treatment centered on bladder-removal surgery, according to a planned interim analysis.
The study targeted patients with muscle-invasive bladder cancer who were either ineligible for cisplatin-based chemotherapy or declined it, a population representing as many as half of patients with the disease because of kidney impairment or other medical conditions.
Muscle-invasive bladder cancer carries a high recurrence risk even after radical cystectomy, the surgical removal of the bladder, creating a significant unmet need for alternatives to cisplatin-based treatment regimens.
The trial also evaluated IMJUDO in combination with IMFINZI and enfortumab vedotin. That regimen achieved a statistically significant improvement in event-free survival, though overall survival data had not yet reached statistical significance at the interim review.
“Up to half of patients with muscle-invasive bladder cancer are not eligible for cisplatin and face high rates of disease recurrence,” trial investigator Thomas Powles of Barts Cancer Centre said.
AstraZeneca indicated the safety profile of the treatment combinations was consistent with previously known risks associated with the individual medicines, with no new safety signals identified.
The results strengthen AstraZeneca’s competitive position in bladder cancer, an increasingly crowded oncology market where drugmakers are racing to expand immunotherapy use into earlier-stage disease before cancer spreads.
IMFINZI is already approved in more than 40 countries for cisplatin-eligible muscle-invasive bladder cancer patients based on data from the NIAGARA Phase III trial.
The company is also seeking regulatory approvals for additional bladder cancer uses tied to its POTOMAC trial and continues studying IMFINZI in metastatic disease through the NILE Phase III program.
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