Mitomycin Shows Durable Disease Control in LG-IR-NMIBC at 3 Years

New 36-month data from the pivotal phase 3 ENVISION trial show that nearly two-thirds of patients who achieved a complete response (CR) with mitomycin for intravesical solution (Zusduri) remained disease-free at 3 years and the median duration of response has still not been reached in patients with recurrent low-grade intermediate-risk non–muscle-invasive bladder cancer (LG-IR-NMIBC).¹

The 36-month duration of response (DOR) rate was 64.5% (95% CI, 54.6%-72.8%) among patients who achieved a CR at 3 months. At a median follow-up of 35.5 months, the median DOR remained not reached. Of note, these durable outcomes were achieved following a single 6-week induction course, with no maintenance therapy required.¹

The results build on a growing body of data from ENVISION showing consistent, sustained response rates across time points. The 3-month CR rate, which was the trial's primary endpoint, was 79.6% with 191 of 240 enrolled patients qualifying as complete responders.² Among those responders, DOR rates held at 82% at 12 months, 72.2% at 24 months, and now 64.5% at 36 months, demonstrating a gradual and predictable decline in the event-free population over time rather than an abrupt loss of response.^1,2,3

"This update from the pivotal ENVISION trial shows that many patients who achieve a complete response with Zusduri remain disease-free through three years," Sandip Prasad, MD, MPhil, director of Genitourinary Surgical Oncology and vice chair of Urology at Morristown Medical Center/Atlantic Health System and principal investigator of the ENVISION trial, stated in a news release. "Among patients who achieved a complete response, the event rate over time has remained stable. Importantly, Zusduri's durability was achieved without maintenance therapy, supporting a treatment approach that can provide lasting disease control while reducing ongoing treatment burden for patients."¹

Safety Profile of Mitomycin in ENVISION Trial

The safety profile observed in the ENVISION trial was consistent with prior reports and was characterized predominantly by mild-to-moderate lower urinary tract adverse events. Treatment-emergent adverse events (TEAEs) occurred in 57% of patients, the most common being dysuria (23%), hematuria (8.3%), urinary tract infection (7.1%), pollakiuria (6.7%), fatigue (5.4%), and urinary retention (5.0%). The majority of TEAEs arose in the first 3 months of treatment and resolved or were resolving. Serious adverse events occurred in 29 of 240 patients (12.1%), of which only 2 were treatment-related (urinary retention and urethral stenosis ) and both resolved.^2,3

ENVISION Trial Design and Patient Characteristics

The ENVISION trial (NCT05243550) was a single-arm, open-label, multinational, multicenter phase 3 study that enrolled 240 adults with recurrent LG-IR-NMIBC across 56 sites in the United States and Europe. Participants had a mean age of 68.8 years, were predominantly male (61%), and had undergone a median of 1 prior TURBT procedure (range, 0-14). Patients received 6 once-weekly intravesical instillations of mitomycin; secondary end points included DOR, disease-free survival, and safety, assessed up to 63 months.²

Mitomycin intravesical solution was approved by the FDA in June 2025 for the treatment of adult patients with LG-IR-NMIBC.

REFERENCES

1. UroGen Pharma Ltd. 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. https://tinyurl.com/3a4utxnn

2. Prasad SM, Shishkov D, Mihaylov NV, et al. UGN-102 for recurrent low-grade intermediate-risk non–muscle-invasive bladder cancer: 24-month duration of response results from the phase 3 ENVISION trial. J Urol. Published March 25, 2026. doi:10.1097/JU.0000000000005041

3. UroGen Pharma Ltd. Journal of Urology publishes ENVISION trial results showing 72.2% 24-month duration of response with ZUSDURI. News release. UroGen Pharma. March 30, 2026. https://tinyurl.com/mryaaxtp