William Huang, MD, highlights data on mitomycin for intravesical solution

Data from a 5-year extension study of the phase 2b OPTIMA II trial (NCT03558503) showed that treatment with mitomycin for intravesical solution (Zusduri, formerly UGN-102) was associated with durable, long-term complete responses (CRs) in patients with low-grade, intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC) who achieved an initial CR to treatment.

Mitomycin intravesical solution was approved by the FDA in June 2025 based on findings from the ENVISION study. In a recent interview with Urology Times®, William C. Huang, MD, discussed how data from OPTIMA II compared with clinical outcomes from the pivotal ENVISION study. Huang is a urologic oncologist at NYU Langone Medical Center in New York, New York.

In the OPTIMA II study, 41 of 63 patients (65%) achieved a CR at 3-month follow-up. Among those who achieved a CR, 25 remained in CR at 12 months.

According to post-approval data, the ENVISION trial demonstrated a 3-month CR rate of 78%, with 79% of responders remaining in CR at 12-month follow-up.²

Huang noted, “If you look at the different cohorts, the OPTIMA II trial included patients that were low-grade, intermediate-risk, but not recurrent. When you look at those who had durable responses, they're much more similar to the patients who are in the ENVISION trial, which is, of course, the trial that resulted in FDA approval. So, these recurrent low-grade patients—not the newly diagnosed low-grade, intermediate-risk patients—have the greatest likelihood of being treated and having a complete response.”

REFERENCES

1. Shore ND, Chevli KK, Saltzstein D, et al. Treatment of low-grade intermediate-risk non-muscle invasive bladder cancer with UGN-102: Outcomes from the 5-year long-term extension study of the single-arm, phase 2b Optima II study. Clinical Genitourinary Cancer. 2025. doi:10.1016/j.clgc.2025.102392

2. FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. News release. US Food & Drug Administration. June 12, 2025. Accessed September 11, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle