Behind Durvalumab's FDA Approval: NIAGARA Trial in MIBC
Matt Galsky, MD, discusses the phase 3 NIAGARA trial that led to the recent FDA approval of durvalumab in muscle-invasive bladder cancer after radical cystectomy.
Matt Galsky, MD, medical oncologist at the Icahn School of Medicine at Mount Sinai, associate director for translational research for the Tisch Cancer Institute, discusses the phase 3 NIAGARA trial (NCT03732677) that led to the recent FDA approval of durvalumab (Imfinzi) for the treatment of patients with muscle-invasive bladder cancer (MIBC) after radical cystectomy.1,2
NIAGARA was a phase 3 randomized, open-label, multicenter, global trial which enrolled adult patients with cisplatin-eligible MIBC with a clinical stage of T2-T4aN0/1M0 who were evaluated and confirmed for radical cystectomy and had urothelial carcinoma with or without divergent differentiation or histologic subtypes. Enrollment was open to patients who had an ECOG performance status of 0 or 1, and a creatinine clearance of at least 40 mL/min.
In the phase 3 study, treatment with durvalumab led to statistically significant and clinically meaningful improvements in event-free survival and overall survival in patients with MIBC post radical cystectomy.
“The main findings that supported the approval were an improvement in the co-primary end point of event-free survival with the addition of perioperative durvalumab, with a hazard ratio of 0.68. There was also an improvement in the secondary end point of overall survival with a hazard ratio of 0.75, so an improvement in event-free survival, an improvement in overall survival, an improvement in several other secondary end points, all pointing in the same direction, and a safety profile which was consistent with the use of durvalumab in other disease contexts,” explains Galsky.
References
FDA approves durvalumab for muscle invasive bladder cancer. News release. FDA. March 28, 2025. Accessed April 2, 2025. https://tinyurl.com/yc57uhb3
Powles T, Van der Heijden MS, Galsky M, et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). Presented at: 2024 ESMO Congress; September 13-17, 2024; Barcelona, Spain. Abstract LBA5.
