Isophoric News · Tuesday, October 27, 2026
Phase 3 VOLGA trial reports better event-free and overall survival with durvalumab plus enfortumab vedotin before bladder removal surgery
In the phase 3 VOLGA trial, patients with muscle-invasive bladder cancer who could not or would not take cisplatin chemotherapy and received durvalumab (Imfinzi) plus three cycles of enfortumab vedotin before surgery, then durvalumab afterward, had event-free survival at 24 months of 63.5%, against 45.1% for surgery alone, MedPage Today reported from the European Society for Medical Oncology congress. Overall survival at 24 months was 78.4% against 69.4%. The trial randomized 695 patients in three arms, 233 to durvalumab plus enfortumab vedotin, 233 to that combination with tremelimumab added and 229 to surgery alone; the results quoted here compare the first arm with surgery alone. Median age of about 72, in 25 countries, and OncLive described it as open-label, meaning patients and doctors knew which treatment was given. A pathologic complete response, meaning no cancer found in the surgical specimen, was 45.1% in the durvalumab and enfortumab vedotin group and 9.6% in the control group, according to MedPage; Urology Times, citing local pathology review, gave 45% (105 of 233) and 10% (22 of 229), and said central independent review found 40% and 8%. Grade 3 or higher adverse events occurred in 71.1% of that group and 50.2% of the control group, according to MedPage Today, which does not say whether these were judged treatment-related; Urology Times and OncoDaily said grade 3 or 4 events judged possibly treatment-related occurred in 30% of the durvalumab and enfortumab vedotin group, and Urology Times gave one possibly treatment-related death in that group. A third arm that added the drug tremelimumab improved event-free survival but had not yet shown a statistically significant overall survival improvement, and had more immune-related adverse events. AstraZeneca, the maker of durvalumab, said the FDA granted priority review to its application for the two-drug combination, with a decision date set in the fourth quarter of 2026, OncLive reported. That is a review, not an approval.
