AstraZeneca PLC (NASDAQ:AZN) on Thursday said interim results from the Phase 3 VOLGA trial showed that perioperative treatment with Imfinzi (durvalumab) and neoadjuvant enfortumab vedotin significantly improved event-free survival and overall survival in patients with muscle-invasive bladder cancer who were ineligible for or declined cisplatin-based chemotherapy.
The study compared the regimen against standard treatment involving radical cystectomy, with or without approved adjuvant therapy.
The European drug giant said the combination delivered statistically significant and clinically meaningful benefits in both key endpoints.
Imfinzi-Imjudo Combination Shows Mixed Results
A treatment arm evaluating perioperative Imfinzi plus Imjudo (tremelimumab) alongside neoadjuvant enfortumab vedotin also demonstrated a statistically significant improvement in event-free survival.
However, while the regimen showed a favorable trend in overall survival, the data did not reach statistical significance during the planned interim analysis. AstraZeneca said the endpoint will be reassessed in a future analysis.
Muscle-invasive bladder cancer accounts for roughly one-quarter of bladder cancer cases. Up to half of patients are unable to receive cisplatin-based chemotherapy because of renal impairment or other comorbidities, leaving surgery as the primary treatment option despite high recurrence rates.
Safety Profile Remained Consistent
AstraZeneca said the safety and tolerability profile of Imfinzi, with or without Imjudo plus enfortumab vedotin, was consistent with the known profiles of the individual therapies, with no new safety signals identified.
The company plans to present the data at a future medical meeting and submit findings to global regulatory authorities.
Imfinzi is already approved in more than 40 countries for cisplatin-eligible muscle-invasive bladder cancer based on the Phase 3 NIAGARA trial.
The therapy is also under regulatory review in several markets for high-risk non-muscle-invasive bladder cancer following the POTOMAC Phase 3 trial results.
AZN Price Action: AstraZeneca shares were down 1.16% at $185.54 at the time of publication Thursday, according to Benzinga Pro.
Over the past month, AZN has declined about 8.4% versus a 8.7% rise in the S&P 500 and is up roughly 0% year-to-date compared to the index’s 9.1% gain.
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