Sandip Prasad, MD, on key data from pivotal ENVISION trial of mitomycin intravesical solution

In a recent interview with Urology Times®, Sandip M. Prasad, MD, MPhil, broke down key findings from the phase 3 ENVISION trial (NCT05243550), which supported the approval of mitomycin intravesical solution (Zusduri; formerly UGN-102) for patients with recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC).¹

Prasad is the vice chair of urology and surgical director of general uro-oncology at Atlantic Health System, Morristown Medical Center, as well as a partner at Garden State Urology in New Jersey.

In total, the ENVISION study enrolled 240 adult patients across 56 sites in the US and Europe. The primary end point for the study was the complete response (CR) rate at 3 months following the first instillation of the therapy. Secondary outcome measures included duration of response (DOR), durable CR rate, disease-free survival, and safety.

Overall, the trial met its primary end point by demonstrating a 78% (95% CI, 72 to 83) CR rate in patients with LG-IR-NMIBC at 3 months following the first instillation of the therapy. Overall, 79% of responders remained in CR at 12 months.

UroGen also recently reported updated data from the trial, showing that treatment with mitomycin intravesical solution led to a 24-month DOR of 72.2% (95% CI, 64.1 to 78.8) among patients who achieved an initial CR to treatment at 3-month follow-up.²

“The nice thing about these topical agents like Zusduri and I think others coming down the line is that they don't really need you to see it,” Prasad explained. “The treatment goes across the entire lining of the urinary system, and so the entire urothelium is exposed to these treatments. So, even if a tumor is really small, it's going to see treatment.”

Prasad reports relevant disclosures with UroGen Pharma, Inc.

REFERENCES

1. FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. News release. US Food & Drug Administration. Published online and accessed June 12, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle

2. UroGen announces 24-month duration of response of 72.2% from the pivotal phase 3 ENVISION trial of ZUSDURI, the first and only FDA-approved medicine for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. News release. UroGen Pharma, Ltd. August 5, 2025. Accessed August 18, 2025. https://investors.urogen.com/news-releases/news-release-details/urogen-announces-24-month-duration-response-722-pivotal-phase-3