ZUSDURI (mitomycin), delivered intravesically via UroGen’s RTGel® technology, demonstrated high and durable complete response (CR) rates in adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer in the Phase 3 ENVISION trial. Post-hoc analysis across EORTC recurrence risk groups showed a 79.6% CR at three months and 72.2% probability of remaining event-free at 24 months, with consistent efficacy across low, intermediate, and high-risk patients. These results suggest that ZUSDURI provides durable tumor control, broad applicability across risk strata, and potential for bladder preservation while reducing the need for radical interventions.
ZUSDURI (mitomycin)
- Manufacturer: UroGen Pharma
- Indication / Patient Population: Adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC), including patients who have failed prior intravesical therapy or are not candidates for cystectomy
- Category: Non-surgical intervention / local pharmacologic therapy
- Route of Administration: Locally, utilizing UroGen’s proprietary RTGel® technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, to induce tumor response
ENVISION Study Design (NCT05243550)
- Study Objective: Assess the durability of complete response (CR) rates achieved with ZUSDURI across European Organisation for Research and Treatment of Cancer (EORTC) recurrence risk cores in adults with recurrent low-grade, intermediate-risk NMIBC following completion of the Phase 3 trial
- Participants: 240 patients with recurrent low-grade, intermediate risk NMIBC who received ZUSDURI (75 mg mitomycin via intravesical reverse thermal hydrogel) and were stratified by EORTC recurrence score groups
- Method: Post-hoc analysis of the Phase 3 single-arm trial data, evaluating complete response rates at 3 months after treatment and event-free survival over 24 months using Kaplan-Meier estimates, stratified by EORTC risk categories
- Readout Categories: low (1-4); intermediate (5-9); high (10-17)
- Complete Response (CR) at 3 months by EORTC risk subgroup (low, intermediate, high)
- Kaplan-Meier event-free probability at 24 months for patients achieving CR in each EORTC group
- Durable response across stratified recurrence risk categories
Primary Outcomes
- High overall CR rate at three months: ZUSDURI achieved a CR rate of 79.6% in the overall treatment population (95% CI: 73.9-84.5%)
- Durable response at 24 months: The overall Kaplan-Meier probability of remaining event-free at 24 months was 72.2% (95% CI: 64.1-78.8%)
- CR rates are consistent across EORTC risk strata:
- Low EORTC score (1-4): 83.9 % CR at three months (95 % CI: 66.3 – 94.5 %)
- Intermediate EORTC score (5-9): 81.2 % CR at three months (95 % CI: 74.9 – 86.4 %)
- High EORTC score (10-17): 60.0 % CR at three months (95 % CI: 32.2 – 83.7 %)
- Recurrence-free durability by subgroup: Among patients achieving CR, the majority remained recurrence-free at 24 months across risk categories, with Kaplan-Meier estimates ~67%-74% depending on EORTC risk group
- Median duration of response not reached: Follow-up data indicated that the median duration of response had not yet been reached in the subgroups analyzed, signifying sustained efficacy across longer observation
- Post-hoc analysis context: These findings derive from post-hoc stratified analysis of 240 patients from the ENVISION trial evaluating ZUSDURI in adults with recurrent low-grade, intermediate-risk NMIBC
Clinical Implications
- ✔ Durable bladder preservation: High CR rates and sustained responses at 24 months suggest patients may avoid or delay radical interventions such as cystectomy, improving quality of life
- ✔ Efficacy across risk strata: Consistent CRs across low, intermediate, and even high EORTC risk groups indicate ZUSDURI could be a broadly applicable option for rcurrent NMIBC, rather than limited to lower-risk patients
- ✔ Potential for reduced surveillance burden: Durable responses may allow longer intervals between cystoscopies or follow-up procedures, easing patient burden and healthcare resource use
- ✔ Strategic sequencing in treatment: Durable responses may allow longer intervals between cystoscopies or follow-up procedures, easing patient burden and healthcare resource use
- ✔ Informed patient counseling: Clinicians can use these data to discuss realistic expectations for remission durability and recurrence risk, supporting shared decision-making
Limitations
- Post-hoc subgroup analysis: The reported CR rates across EORTC risk groups come from post-hoc stratification, which is exploratory and not powered for definitive conclusions.
- Single-arm study design: Without a randomized comparator, it’s difficult to directly attribute outcomes solely to ZUSDURI or compare efficacy versus standard therapies like BCG or other intravesical agents.
- Limited high-risk patient numbers: The high EORTC risk group was relatively small, leading to wide confidence intervals, thus reducing certainty about efficacy in this subgroup.
- Short- to mid-term follow-up for some patients: Although 24-month recurrence-free estimates are reported, the median duration of response has not yet been reached; long-term durability and late recurrences remain unknown.
- Generalizability: The trial included adults with recurrent low-grade, intermediate-risk NMIBC; results may not extrapolate to higher-grade, muscle-invasive, or treatment-naive populations.
Sources:
- UroGen Pharma Ltd. ZUSDURI™ achieves durable complete responses across EORTC risk groups in patients with recurrent LG‑IR‑NMIBC [press release]. Published February 27, 2026. GlobeNewswire. Accessed March 24 2026.
- ClinicalTrials.gov. Study of UGN‑102 (mitomycin) for Treatment of Low‑Grade Intermediate‑Risk Non‑Muscle Invasive Bladder Cancer (ENVISION). ClinicalTrials.gov Identifier: NCT05243550. Updated results posted. Accessed March 24, 2026.
