Clinical TrialMay 13, 2026, 08:02 AM
UroGen Pharma ZUSDURI 64.5% Event-Free at 3 Years in ENVISION Trial
AI Summary
UroGen Pharma announced positive 36-month duration of response (DOR) data from the pivotal Phase 3 ENVISION trial of ZUSDURI for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The data showed a 64.5% probability of remaining event-free at three years in patients who achieved a complete response (CR) at three months (79.6%). This durability was achieved without maintenance therapy, offering a non-surgical, in-office treatment that can reduce the burden of repeated TURBT procedures for patients.
Key Highlights
- ZUSDURI showed a 36-month duration of response (DOR) of 64.5% (95% CI, 54.6% - 72.8%) by Kaplan-Meier estimate.
- Patients achieved a complete response (CR) at three months at a rate of 79.6% in the Phase 3 ENVISION trial.
- At a median follow-up of 35.5 months, the median DOR had not been reached.
- Durable outcomes were achieved without the need for maintenance therapy.
- Serious adverse reactions occurred in 12% of patients, including urinary retention (0.8%) and urethral stenosis (0.4%).
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