Mitomycin Reverse Thermal Gel Shows Complete Response in LG-IR-NMIBC

Sam S. Chang, MD, MBA, professor in the Department of Urology, Patricia and Rodes Hart professor of urologic surgery, chief in the Division of Urologic Oncology, and chief surgical officer at Vanderbilt Ingram Cancer Center, discusses the findings backing the FDA approval for intravesical mitomycin (Zusduri; formerly UGN-102) in low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG-IR-NMIBC).

The ATLAS (NCT04688931) and ENVISION (NCT05243550) trials looked at the mitomycin gel in patients with LG-IR-NMIBC. Where ATLAS focused on safety data, ENVISION investigated the efficacy of this treatment in bladder cancer, Chang explains.

In ENVISION, a phase 3 trial, mitomycin showed a complete response rate of 78% at 3 months, with 79% of patients having no evidence of disease at 1 year. Chang says this response was achieved with adverse events similar to other intravesical therapies.

TRANSCRIPTION

0:10 | Two main studies that were evaluated by the FDA were ATLAS and ENVISION. And really, ATLAS is more supportive in actually looking at safety data. It's really the ENVISION study which looked at those patients who had recurrent intermediate-risk cancer. [We] looked at the results within that phase 3 trial, and what we found was a complete response rate of almost 80% at the 3-month mark.

0:45 | What that means is these are patients who were known to have tumors, who actually had visualized tumors, who, after receiving the treatment course—an induction course initially of 6 weeks of this medication—at that 3-month mark, 78% of patients actually had no evidence of disease. In fact, of those patients that achieved this complete response, almost 80% at the 1-year mark, that's actually 79% were free of disease, did not have disease based upon the installation of the reverse thermal gel. This was actually done with [adverse events] very, very similar to those seen with other intravesical therapies.