AstraZeneca’s Phase III VOLGA trial showed perioperative Imfinzi plus neoadjuvant enfortumab vedotin significantly improved event-free and overall survival in cisplatin-ineligible or cisplatin-declining patients with muscle-invasive bladder cancer.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
AstraZeneca announced positive interim results from the Phase III VOLGA trial (NCT04960709) showing that perioperative treatment with Imfinzi (durvalumab) 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.
The perioperative regimen included neoadjuvant therapy before radical cystectomy and continued adjuvant therapy after surgery. Patients in the control arm underwent cystectomy with or without standard adjuvant treatment.
A second experimental arm evaluating Imfinzi plus Imjudo (tremelimumab) together with enfortumab vedotin also achieved a statistically significant improvement in EFS. OS data showed a favorable trend but did not reach statistical significance at interim analysis and will be reassessed with longer follow‑up.
MIBC accounts for roughly one‑quarter of bladder cancer cases and carries high recurrence rates and poor outcomes even after surgery. Up to half of patients are unable to receive cisplatin‑based chemotherapy due to impaired kidney function or comorbidities, highlighting the need for alternative strategies.
Thomas Powles, international coordinating investigator, said perioperative durvalumab plus enfortumab vedotin extended survival while maintaining a manageable safety profile in patients treated with curative intent.
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, added that VOLGA strengthens Imfinzi’s role as a potential immunotherapy backbone in early‑stage bladder cancer, building on positive results from NIAGARA (NCT03732677) and POTOMAC (NCT03528694).
Safety findings were consistent with known profiles of the individual medicines, with no new signals observed. AstraZeneca plans to present full data at an upcoming medical meeting and submit results to global regulatory authorities.
VOLGA enrolled 695 patients across 182 centers in 25 countries. Dual primary endpoints were EFS for both experimental arms versus control; secondary endpoints included OS, pathological complete response, disease‑free survival, and pathologic downstaging.
Imfinzi is already approved in over 40 countries for cisplatin‑eligible MIBC based on the NIAGARA trial and continues to be studied across earlier and advanced bladder cancer settings.
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About the Writer
Sana Jamil Khan (LinkedIn) is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.