WILMINGTON, Del. — AstraZeneca said a Phase III trial of IMFINZI in combination with neoadjuvant enfortumab vedotin showed statistically significant and clinically meaningful improvements in event-free survival and overall survival in patients with muscle-invasive bladder cancer.
The results came from a planned interim analysis of the VOLGA Phase III trial. The study evaluated perioperative IMFINZI, also known as durvalumab, with neoadjuvant enfortumab vedotin in patients with muscle-invasive bladder cancer who were ineligible for or had declined cisplatin-based chemotherapy.
Patients in the comparator arm underwent radical cystectomy, or bladder-removal surgery, with or without approved adjuvant treatment.
AstraZeneca also said perioperative IMFINZI plus IMJUDO, also known as tremelimumab-actl, in combination with neoadjuvant enfortumab vedotin showed a statistically significant and clinically meaningful improvement in event-free survival and a favorable trend in overall survival. The company said the overall survival data for that regimen were not statistically significant at the interim analysis and will be reassessed in a later analysis.
Muscle-invasive bladder cancer occurs when the tumor invades the muscle wall of the bladder without distant metastases. AstraZeneca said about one in four bladder cancer patients has muscle-invasive disease, and as many as half of those patients are ineligible for cisplatin-based chemotherapy because of impaired kidney function or other health conditions.
“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,” said Thomas Powles, MD, Professor, Chair of Barts Cancer Centre (QMUL), London, UK, and International Coordinating Investigator for the trial. “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 at AstraZeneca, said the interim analysis supports the potential role of IMFINZI in early-stage bladder cancer treatment.
“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,” Galbraith said. “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.”
AstraZeneca said the safety and tolerability of IMFINZI with or without IMJUDO plus enfortumab vedotin were consistent with the known profiles of the individual medicines, and no new safety signals were identified.
The company said the data will be presented at an upcoming medical meeting and shared with global regulatory authorities.
IMFINZI is approved in more than 40 countries for cisplatin-eligible patients with muscle-invasive bladder cancer based on the NIAGARA Phase III trial. AstraZeneca said IMFINZI is also under regulatory review in the U.S., European Union, Japan and other countries for high-risk non-muscle-invasive bladder cancer when added to Bacillus Calmette-Guérin therapy, based on the POTOMAC Phase III trial.
