AstraZeneca reported positive results from its Phase III VOLGA trial of Imfinzi (durvalumab) plus neoadjuvant enfortumab vedotin in patients with muscle-invasive bladder cancer (MIBC). The trial enrolled patients who were ineligible for or had refused cisplatin-based chemotherapy. Results were presented at the European Society for Medical Oncology (ESMO) Congress 2026.
An estimated 78% of patients who received the combination were alive at two years. The figure was 69% in the standard-of-care arm. The combination reduced the risk of death by 42% and the risk of disease progression, recurrence or death by 49%.
In September 2026, the FDA granted the combination Priority Review based on the VOLGA trial findings.