Clinical TrialMay 14, 2026, 07:31 AM
AstraZeneca's Imfinzi + EV improves EFS & OS in bladder cancer
AI Summary
AstraZeneca announced positive high-level results from the Phase III VOLGA trial, showing that perioperative Imfinzi combined with neoadjuvant enfortumab vedotin significantly improved event-free survival (EFS) and overall survival (OS) in patients with muscle-invasive bladder cancer (MIBC) who were ineligible for or declined cisplatin-based chemotherapy. A regimen of Imfinzi plus Imjudo and neoadjuvant EV also demonstrated significant EFS improvement and a favorable OS trend. These results highlight a novel treatment option for a patient population with high unmet medical need, with a manageable safety profile.
Key Highlights
- Perioperative Imfinzi plus neoadjuvant enfortumab vedotin (EV) significantly improved event-free survival (EFS) and overall survival (OS) in muscle-invasive bladder cancer (MIBC).
- The VOLGA Phase III trial included MIBC patients ineligible for or who declined cisplatin-based chemotherapy.
- Perioperative Imfinzi plus Imjudo and neoadjuvant EV also showed statistically significant EFS improvement.
- Overall survival data for the Imfinzi plus Imjudo arm showed a favorable trend but was not statistically significant at this interim analysis.
- The safety and tolerability profile was consistent with known individual medicines, with no new safety signals identified.
- Results will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
- Approximately one in four patients with bladder cancer has muscle-invasive disease.
- Up to 50% of MIBC patients are ineligible for cisplatin-based chemotherapy, facing high recurrence rates.