On February 27, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative, non-surgical therapies for urothelial and specialty cancers, reported new post-hoc analyses from the Phase 3 ENVISION trial showing that ZUSDURI (mitomycin) for intravesical solution (formerly known as UGN-102) achieved durable complete response (CR) rates across European Organization for Research and Treatment of Cancer (EORTC) recurrence score groups in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). A poster including the ENVISION trial EORTC recurrence score analysis will be presented at ASCO (Free ASCO Whitepaper)-GU 2026, which is being held February 26-28, 2026, in San Francisco, CA, and virtually.
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CR rates at three months were 83.9%, 81.2%, and 60.0% in patients with low (1-4), intermediate (5-9), and high (10-17) EORTC recurrence scores, respectively, with the majority of responders across all groups remaining recurrence-free at 24 months.
"These results are particularly meaningful because they demonstrate that ZUSDURI can achieve robust complete response rates, even in patients with a higher baseline risk of recurrence," said Sandip M. Prasad, MD, M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, NJ, and Principal Investigator of the ENVISION trial. "Importantly, the durability of response observed with ZUSDURI across EORTC risk categories highlights a meaningful advance for patients with recurrent LG-IR-NMIBC, a population with limited treatment options."
The Phase 3 ENVISION (NCT05243550) trial evaluated ZUSDURI, a reverse thermal hydrogel administered intravesically containing 75 mg mitomycin, in patients with recurrent LG-IR-NMIBC. In the overall study population, ZUSDURI achieved a CR rate of 79.6% at three months (95% CI: 73.9–84.5), with a Kaplan-Meier probability of remaining event-free at 24 months of 72.2% (95% CI: 64.1–78.8).
In the post-hoc analysis of 240 treated patients stratified by EORTC recurrence score, high CR rates were observed across all risk groups at three months. CR rates were 83.9% (95% CI: 66.3–94.5) in patients with EORTC scores of 1–4, 81.2% (95% CI: 74.9–86.4) in patients with EORTC scores of 5–9, and 60.0% (95% CI: 32.2–83.7) in patients with EORTC scores of 10–17. Among patients achieving a CR, the majority remained recurrence-free at 24 months across all groups, with a Kaplan-Meier probability of remaining event-free of 67.4% (95% CI: 43.2–83.1), 73.7% (95% CI: 64.6–80.8), and 66.7% (95% CI: 28.2–87.8) for the EORTC score groups of 1–4, 5–9, and 10–17, respectively. Across the subgroups, Kaplan-Meier estimate of median duration of response was not reached, reflecting low recurrence event rates during follow-up.
"The consistency of response we’re seeing across EORTC recurrence score groups reinforces the therapeutic benefit of ZUSDURI," said Mark Schoenberg, MD, Chief Medical Officer, UroGen. "These findings build on the strong primary results from ENVISION and further support ZUSDURI as a non-surgical treatment option designed to address the chronic and recurrent nature of this disease."
Despite the post-hoc design and small sample sizes in some subgroups, the results suggest that ZUSDURI may provide durable and clinically meaningful benefit, regardless of baseline recurrence risk. Patients in ENVISION will continue to be followed for recurrence and progression for up to five years. The EORTC is an international academic research organization that conducts large multicenter clinical trials and develops widely validated prognostic and risk-stratification tools. Its bladder cancer recurrence score tables are commonly used to estimate recurrence risk based on established clinical and pathological factors.
About ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin approved for the treatment of adults with recurrent LG-IR-NMIBC. 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, thereby enabling the treatment of tumors by non-surgical means.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.
(Press release, UroGen Pharma, FEB 27, 2026, View Source [SID1234663132])