Sandip Prasad, MD, highlights 3-year data on mitomycin for intravesical solution for LG-IR-NMIBC

In this video, Sandip M, Prasad, MD, MPhil, highlights updated 3-year data from the phase 3 ENVISION trial (NCT05243550) evaluating mitomycin for intravesical solution (ZUSDURI) for the management of recurrent low-grade intermediate-risk non–muscle-invasive bladder cancer (LG-IR-NMIBC).¹ Prasad is the director of genitourinary surgical oncology and vice chair of urology at Morristown Medical Center/Atlantic Health System in New Jersey.

The ENVISION trial evaluated the safety and efficacy of mitomycin for intravesical solution, a reverse thermal gel formulation of mitomycin designed to prolong drug contact with the bladder urothelium. In the single-arm phase 3 trial, 240 patients with recurrent LG-IR-NMIBC received 6 weekly intravesical instillations of mitomycin for intravesical solution. Following treatment, patients underwent cystoscopic assessment to determine whether tumors had been eradicated without the need for TURBT.

In the pivotal trial, 79.6% of patients achieved a complete response (CR) at 3 months. Among those responders, the Kaplan-Meier estimated duration of response at 36 months was 64.5% (95% CI, 54.6 to 72.8). At a median follow-up of 35.5 months, the median duration of response had not yet been reached. Prasad emphasized that many enrolled patients had experienced recurrence within the previous year and often had multiple tumors, making the long-term disease control particularly notable. According to Prasad, the findings suggest that a substantial proportion of patients can remain disease-free for years after a single induction course of therapy.

Regarding safety, Prasad noted that the treatment demonstrated a consistent and manageable adverse event (AE) profile. Because ENVISION did not include maintenance therapy, most treatment-related AEs occurred early during or shortly after treatment, with few new safety concerns emerging during long-term follow-up. The most common AEs reported in the study included dysuria, increased potassium, increased creatinine, decreased hemoglobin, increased eosinophils, increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. AEs were generally mild to moderate. Serious AEs occurred in 12% of patients and included urinary retention (0.8%) and urethral stenosis (0.4%).

REFERENCE

1. ZUSDURI median duration of response still not reached with 64.5% 36-month duration of response in the pivotal ENVISION trial. News release. UroGen. May 13, 2026. Accessed June 19, 2026. https://www.globenewswire.com/news-release/2026/05/13/3293931/0/en/zusduri-median-duration-of-response-still-not-reached-with-64-5-36-month-duration-of-response-in-the-pivotal-envision-trial.html