A new 36-month update from UroGen Pharma's (URGN) pivotal Phase 3 ENVISION trial showed that many patients who achieved an early complete response with ZUSDURI (mitomycin) remained disease-free through three years, reinforcing the therapy's durability in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
The analysis found a 64.5% probability of remaining event-free at 36 months among patients who achieved a complete response at three months, based on Kaplan-Meier estimates.
At a median follow-up of 35.5 months, the median duration of response has not yet been reached, indicating that responses continue beyond the current observation window.
Investigators noted that the durability was achieved without maintenance therapy, suggesting a potential shift away from repeated surgical procedures such as TURBT, the current standard of care. ZUSDURI is administered as a non-surgical, in-office intravesical treatment using UroGen's RTGel sustained release, hydrogel-based formulation.
The Phase 3 ENVISION trial enrolled 240 patients across 56 sites and evaluated ZUSDURI as a chemoablative option for adults with recurrent LG-IR-NMIBC. The primary endpoint measured complete response at three months, while durability of response serves as a key secondary endpoint.
Common adverse reactions were mostly mild to moderate and included dysuria, urinary tract infection, and laboratory abnormalities. Serious adverse reactions occurred in 12% of patients.
URGN has traded between $3.42 and $32.37 over the past year. The stock is currently trading at $29.51, down 0.97%.
For comments and feedback contact: editorial@rttnews.com
Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.