Las Vegas, Nevada (UroToday.com) -- High-level results from a planned interim analysis of the VOLGA Phase III trial showed perioperative treatment with IMFINZI® (durvalumab) in combination with neoadjuvant enfortumab vedotin (EV) demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) in patients with muscle-invasive bladder cancer (MIBC) versus standard of care. Patients were ineligible for or had declined cisplatin-based chemotherapy. Patients in the comparator arm had a radical cystectomy (surgery to remove the bladder) with or without approved adjuvant treatment.
Perioperative IMFINZI plus IMJUDO® (tremelimumab-actl) in combination with neoadjuvant EV demonstrated a statistically significant and clinically meaningful improvement in EFS and a favorable trend for OS; however, the OS data were not statistically significant at this planned interim analysis and will be formally reassessed at a subsequent analysis.
Approximately one in four patients with bladder cancer has muscle-invasive disease, where the tumor invades the muscle wall of the bladder, without distant metastases.1,2 As many as 50% of patients are ineligible for cisplatin-based chemotherapy due to impaired renal function or comorbidities.3,4 The standard treatment for these patients has historically been radical cystectomy alone, but despite undergoing this major surgery, patients experience high rates of recurrence and have a poor prognosis.3-5
Thomas Powles, MD, Professor, Chair of Barts Cancer Centre (QMUL), London, UK, and International Coordinating Investigator for the trial, said: “Up to half of patients with muscle-invasive bladder cancer are not eligible for cisplatin and face high rates of disease recurrence, even after having their bladder removed, leaving a significant need for new effective and well-tolerated treatments. The VOLGA results show that perioperative durvalumab significantly extends event-free survival and overall survival when combined with neoadjuvant enfortumab vedotin, with a manageable safety profile, compared to surgery for patients in this curative-intent setting.”Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “This interim analysis from the VOLGA trial highlights the benefit of perioperative IMFINZI with neoadjuvant enfortumab vedotin compared to surgery, a novel regimen that optimizes treatment options for patients. Together with NIAGARA and POTOMAC, VOLGA is our third positive readout in bladder cancer, setting a strong foundation for IMFINZI as the immunotherapy backbone in this early-stage, curative-intent setting.”
The safety and tolerability of IMFINZI with or without IMJUDO plus EV were consistent with the known safety profiles of the individual medicines, with no new safety signals identified. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
IMFINZI is approved in over 40 countries for patients with cisplatin-eligible MIBC, based on the NIAGARA Phase III trial. Additionally, IMFINZI added to Bacillus Calmette-Guérin therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial and is currently under review in the US, European Union (EU), Japan, and several other countries. IMFINZI is also being investigated in locally advanced or metastatic disease in the NILE Phase III trial.
References:
- Burger M, et al. Epidemiology and Risk Factors of Urothelial Bladder Cancer. Eur Urol. 2013;63(2):234-241.
- National Collaborating Centre for Cancer. Bladder Cancer: Diagnosis and Management. London: National Institute for Health and Care Excellence (NICE). Available at: https://www.ncbi.nlm.nih.gov/books/NBK356289/. Accessed May 2026.
- Dash A, et al. Impact of renal impairment on eligibility for adjuvant cisplatin-based chemotherapy in patients with urothelial carcinoma of the bladder. Cancer. 2006;107(3):506-513.
- Galsky MD, et al. Treatment of patients with metastatic urothelial cancer “unfit” for cisplatin-based chemotherapy. J Clin Oncol. 2011;29(17):2432-2438.
- Van der Heijden AG, et al. EAU Guidelines on Muscle-invasive and Metastatic Bladder Cancer. 2026. Edn. Presented at the EAU Annual Congress Copenhagen 2026. ISBN 978-94-92671-30-1.