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Opinion|Videos|October 15, 2026
Three-year data show durable responses with mitomycin intravesical solution
Author(s)Sandip M. Prasad, MD, MPhil
Fact checked by: Hannah Clarke
Sandip M. Prasad, MD, MPhil, discusses 3-year ENVISION trial data showing durable responses with mitomycin intravesical solution for recurrent LG-IR-NMIBC.
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In this video, Sandip M. Prasad, MD, MPhil, highlights efficacy findings from the phase 3 ENVISION trial (NCT05243550) of mitomycin intravesical solution (Zusduri) for recurrent low-grade intermediate-risk non-muscle-invasive
In ENVISION, 79.6% of patients achieved a complete response 3 months after receiving intravesical mitomycin, which is administered in an office setting once weekly for 6 weeks. Among patients who achieved a complete response, the estimated probability of remaining event-free at 36 months was 64.5% (95% CI, 54.6 to 72.8) by Kaplan-Meier analysis. At a median follow-up of 35.5 months, the median duration of response had not been reached.
Prasad highlights the durability of these responses in the absence of maintenance therapy, noting that patients underwent regular cystoscopic surveillance during follow-up but did not receive additional treatment as part of the study. The findings are particularly relevant for patients with recurrent LG-IR-NMIBC, who often undergo repeated transurethral resection of bladder tumors (TURBT). According to Prasad, follow-up in ENVISION will continue for a total of 5 years to assess longer-term outcomes.
“The biggest issue with low-grade intermediate-risk non-muscle-invasive bladder cancer is recurrence,” Prasad explained. “If we can show that patients who are complete responders maintain a long-term complete response, that changes the way in which these patients typically behave, which is that we resect them, but they typically recur.”
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REFERENCES
1. Prasad SM, Shishkov D, Mihaylov NV, et al. Primary chemoablation of recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer With UGN-102: A single-arm, open-label, phase 3 trial (ENVISION). J Urol. 2025;213(2):205-216. doi:10.1097/JU.0000000000004296
2. ZUSDURI median duration of response still not reached with 64.5% 36-month duration of response in the pivotal ENVISION trial. News release. UroGen Pharma. May 13, 2026. Accessed October 12, 2026.
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