AstraZeneca said Saturday that its combination of durvalumab and enfortumab lowered the risk of bladder cancer returning or related events by 49% and the risk of death by 42% in people whose bladder cancer had grown into the bladder muscle and who could not take cisplatin or chose not to take it.
The Phase 3 VOLGA trial enrolled 695 patients. It compared treatment approaches given before and after bladder-removal surgery with standard care based on surgery. In the combination group, patients received three cycles of enfortumab vedotin and durvalumab before surgery.
They then received durvalumab after surgery. After a median follow-up of about 23 months, an estimated 64% of patients in that group were alive without an event at two years, compared with 45% in the control group. The estimated overall-survival rates at two years were 78% in the combination group and 69% in the control group.
Median overall survival had not yet been reached in either group. A separate treatment plan that also included tremelimumab improved the time patients went without an event. However, its early result for overall survival was not statistically significant.
The results were presented at the European Society for Medical Oncology Congress. They were also published in The New England Journal of Medicine. The U.S. FDA granted the combination Priority Review in September.
That review is not an approval. Longer follow-up will help show how long the benefits last.