Expert describes implications of neoadjuvant durvalumab approval in MIBC

One of the top stories in urology in the first quarter of 2025 was the FDA’s approval of neoadjuvant durvalumab (Imfinzi) in combination with gemcitabine and cisplatin, followed by adjuvant durvalumab monotherapy following radical cystectomy, for adult patients with muscle invasive bladder cancer (MIBC).¹ In a recent video interview with Urology Times^®, Joshua J. Meeks, MD, PhD, was asked about what practical considerations, such as infusion scheduling, monitoring for immune-related adverse events, and patient education, will be important to implement when incorporating this new treatment paradigm into routine clinical practice.

“From a urology perspective, I don't think we're going to see any difference,” said Meeks, an associate professor of urology at Northwestern University Feinberg School of Medicine in Chicago, Illinois and an investigator on the NIAGARA trial evaluating the treatment regimen.

“Jim Catto [MB ChB, PhD, FRCS(Urol)], presented the surgical data at EAU, and that data look great. There were no significant delays in time to surgery. There really wasn't a difference in in surgical outcomes. The patients tolerated it very well,” Meeks added.

Meeks was also asked for his thoughts on the long-term efficacy and safety of the treatment regimen.

“For muscle-invasive bladder cancer, what we really look at is a 2-year window after surgery. If you look at all of our surveillance regimens, as far as imaging and any kind of urine biomarkers and everything else, they pretty much changed dramatically at 2 years. That 2-year cut point really is the most important thing. Obviously, immune-related [adverse events] are often long term, and many people may unfortunately carry that burden for longer than that 2-year landmark. But for the most part, I would say that from an outcome perspective, I think most of us are pretty happy at 2 years. Even though it's still a relatively new regimen for people to consider, honestly, a lot of those patients were undergoing adjuvant immunotherapy anyway,” Meeks commented.

REFERENCE

1. FDA approves durvalumab for muscle invasive bladder cancer. News release. US Food & Drug Administration. Published online and accessed March 28, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer