William Huang, MD, outlines OPTIMA II data on mitomycin for intravesical solution

Data from a 5-year extension study of the phase 2b OPTIMA II trial (NCT03558503) were recently published in Clinical Genitourinary Cancer.^1,2 Overall, data 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.

In a recent interview with Urology Times®, William C. Huang, MD, outlined the key findings and implications from the long-term study.

“This was the first study to demonstrate not only the efficacy in this patient population, but also the first study to demonstrate that chemoablation was a feasible treatment option for treatment of these types of tumors,” Huang noted. Huang is a urologic oncologist at NYU Langone Medical Center in New York, New York.

In total, the study included 63 patients, of whom 41 achieved a complete response (CR) at 3-month follow-up. Among those who achieved a CR, 25 remained in CR at 12 months and 17 entered into the long-term follow-up study.

Among the 17 patients in the long-term follow-up study, the median DOR was 42.1 months (95% CI, 24.2 to NE), and the median follow-up was 50.4 months. According to the authors, “Eight patients experienced recurrence of LG disease, 1 had progression to [high-grade] disease, 1 patient died (not due to bladder cancer), 5 discontinued the study, and 2 were still in CR at the end of the study period).”

Huang noted, “The thing that was highlighted by this study and subsequently confirmed with future studies was the fact that not only did [treatment] result in primary chemoablation of these tumors, but it actually provided a durable treatment response, which is very important for these patients, because the hallmark of patients with low-grade intermediate-risk disease is that they tend to frequently recur.”

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. Long-term extension study of the OPTIMA II trial demonstrates long-term durability of response to ZUSDURI in patients with low-grade intermediate-risk non-muscle invasive bladder cancer. News release. UroGen Pharma Ltd. July 21, 2025. Accessed September 8, 2025. https://investors.urogen.com/news-releases/news-release-details/urogen-announces-five-year-long-term-extension-study-optima-ii