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UroGen Announces Updated 18-Month Duration of Response (DOR) of 80.6% from the Phase 3 ENVISION Trial of UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)
18-month DOR of 80.6% by Kaplan-Meier estimate was attained in patients who achieved a complete response (CR) at three months (79.6%) Data unveiled during a
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n\n18-month DOR of 80.6% by Kaplan-Meier estimate was attained in patients who achieved a complete response (CR) at three months (79.6%)\n\n\nData unveiled during a Podium Presentation at the American Urological Association (AUA) 2025 Annual Meeting in Las Vegas, Nevada\n\n\n PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced an updated 18-month DOR of 80.6% (95% CI: 74.0, 85.7), by Kaplan-Meier estimate, from the Phase 3 ENVISION trial of UGN-102 (mitomycin) for intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC. These data were featured today in an Oral Presentation Session (Abstract ID: PD12) at the AUA 2025 Annual Meeting in Las Vegas, Nevada.\n\n“This new update from the pivotal ENVISION trial of UGN-102 demonstrated a compelling probability of remaining in complete response of 80.6% at 18 months in patients who achieved a complete response (CR) at three months (79.6%),\" said Sandip Prasad M.D., M.Phil., Director of Genitourinary Surgical Oncology, Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, NJ, and Principal Investigator of the ENVISION trial. “Low-grade bladder cancer is a persistent cancer that frequently recurs and comes with its own risks. There is a significant unmet need in finding treatment options for patients with recurrent low-grade bladder cancer.”\n\nThe existing standard of care for LG-IR-NMIBC is an invasive surgical procedure requiring anesthesia called transurethral resection of bladder tumor (TURBT). Repeated TURBT procedures can impact patients’ physical health and quality of life and are even associated with an increased risk in mortality. Due to high recurrence rates, LG-IR-NMIBC patients, who are typically elderly with comorbidities, will likely need multiple TURBTs under general anesthesia over the course of their lifetime. An estimated 59,000 patients with LG-IR-NMIBC recur annually and face the burden and risks of repeat surgeries that often provide limited value.\n\nMark Schoenberg, M.D., Chief Medical Officer of UroGen, stated, \"The duration of response data from the ENVISION trial further underscores UGN-102’s potential to positively impact the treatment landscape for patient...