AstraZeneca bladder cancer regimen cuts progression and death risks in VOLGA trial
AstraZeneca reported positive Phase III VOLGA results for perioperative IMFINZI plus neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer patients unable or unwilling to receive cisplatin-based chemotherapy. At the March 2, 2026 data cutoff, the regimen reduced the risk of an event covered by EFS by 49% and the risk of death by 42% versus surgery with or without approved adjuvant treatment. Overall survival at two years was 78% with the combination versus 69% for the comparator, while median overall survival was not yet reached in either group. The results were presented at the ESMO Congress on October 24, 2026, after the FDA granted the regimen Priority Review in September 2026.
Why it matters
The data strengthen AstraZeneca's case in an FDA review for cisplatin-ineligible or cisplatin-refusing patients, but the Priority Review does not establish approval. Grade 3 and 4 adverse events occurred in 64% of combination-treated patients versus 44% in the comparator group, an important consideration for treatment adoption.
Key facts
- 1The VOLGA trial enrolled 695 patients randomized across 182 centers in 25 countries. marketscreener.com
- 2The combination produced an EFS hazard ratio of 0.51, corresponding to a 49% reduction in the risk of progression, recurrence, failure to undergo surgery or death. finanznachrichten.de
- 3The overall-survival hazard ratio was 0.58, corresponding to a 42% reduction in the risk of death versus the comparator. finanznachrichten.de
- 4At 24 months, overall survival was 78% with perioperative IMFINZI plus neoadjuvant EV and 69% with radical cystectomy with or without approved adjuvant treatment. finanznachrichten.de
- 5The FDA granted Priority Review in September 2026 for patients with muscle-invasive bladder cancer who are ineligible for or have refused cisplatin-based chemotherapy. finanznachrichten.de
- 6Grade 3 and 4 adverse events from any cause occurred in 64% of patients receiving the combination and 44% of comparator patients. marketscreener.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.