UroGen’s ZUSDURI Achieves 60–83.9% CR Rates Across EORTC Risk Groups
UroGen Pharma’s ZUSDURI intravesical solution achieved complete response rates of 83.9%, 81.2% and 60.0% at three months in low, intermediate and high EORTC risk groups, with 67–74% of responders remaining recurrence-free at 24-month follow-up. Post-hoc analysis of 240 patients confirms durable efficacy across all risk categories.
1. Phase 3 ENVISION Trial Overview
The ENVISION trial evaluated ZUSDURI, a reverse thermal hydrogel formulation containing 75 mg mitomycin, in 240 adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, administering intravesical treatment in an outpatient setting to assess non-surgical efficacy.
2. Post-hoc EORTC Risk-Stratified Efficacy
A post-hoc analysis stratified by European Organization for Research and Treatment of Cancer (EORTC) recurrence scores showed three-month complete response rates of 83.9% in low (1–4), 81.2% in intermediate (5–9) and 60.0% in high (10–17) risk groups, demonstrating robust responses across all categories.
3. 24-Month Durability Outcomes
Kaplan-Meier estimates indicated that 67.4%, 73.7% and 66.7% of responders in the low, intermediate and high EORTC groups respectively remained recurrence-free at 24 months, with median duration of response not reached across subgroups.
4. Implications for Non-Surgical Bladder Cancer Treatment
Durable efficacy across all risk groups underscores ZUSDURI’s potential as a non-surgical therapeutic option for recurrent LG-IR-NMIBC, addressing high recurrence rates and reducing the need for repeated surgical interventions.