Joshua J. Meeks, MD, PhD, discusses the impact of neoadjuvant durvalumab approval in MIBC

The FDA recently approved 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, an associate professor of urology at Northwestern University Feinberg School of Medicine in Chicago, Illinois and an investigator on the NIAGARA trial evaluating this treatment regimen, discussed the impact of the approval.

“The NIAGARA approval really begins to bring immunotherapy into the neoadjuvant setting. As providers who care for patients with muscle-invasive bladder cancer, we've become very familiar with giving chemotherapy to those who can get it; those who can't go to surgery. Either way, you do an operation, and then, based on the pathology, you make a decision about adjuvant immunotherapy. That’s the paradigm up until NIAGARA. NIAGARA changes that in a bunch of ways. First, if you look at the creatinine clearance for patients who are cis eligible—and everyone got GC as a backbone—they went down to 45, so that begins to increase the window of patients. I've heard medical oncologists concerned about giving chemotherapy to patients with a GFR of 59, so going down to 45 increases that pool of patients. That should be identified. In addition, there’s a statistically significant improvement in path response in patients who got durvalumab,” Meeks said.

Meeks added, “My sense is that it's something that going to start being offered to more patients, in general, because again, the people who are electing to do chemotherapy are usually wanting a full-court press, and this gives them another chance to intensify that and give a better chance to fight for survival.”

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