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The Journal of Urology Publishes Peer-Reviewed Article Highlighting UGN-102 Data in Non-Surgical Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
-- Phase 3 ATLAS Clinical Trial Shows UGN-102 Demonstrated Superiority to TURBT with a 55% Reduction of Risk for Recurrence, Progression or Death in Patients
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n-- Phase 3 ATLAS Clinical Trial Shows UGN-102 Demonstrated Superiority to TURBT with a 55% Reduction of Risk for Recurrence, Progression or Death in Patients who Received UGN-102 --\n\n\n PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that The Journal of Urology published data from the Phase 3 ATLAS trial for investigational agent UGN-102 (mitomycin) for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), that demonstrated superiority to transurethral resection of bladder tumor surgery (TURBT) with a 55% reduction of risk for recurrence, progression, or death in patients who received UGN-102. Tumor-free complete response rate at three months was 65% for patients who only received UGN-102, compared to a 64% complete response rate at three months for patients who underwent TURBT. TURBT is the current standard of care for patients with this type of cancer.\n\n\n“The publication of our ATLAS data in The Journal of Urology adds another chapter to our understanding of the potential of UGN-102 as a treatment for patients with LG-IR-NMIBC, who often face multiple surgeries due to the recurring nature of this cancer,” said Mark Schoenberg, M.D., Chief Medical Officer at UroGen. “Our hope is that one day urologists may have an effective, non-surgical therapy option beyond TURBT that can be used to address this large patient population.”\n\n\nThe Phase 3 ATLAS clinical trial, which met its primary endpoint, evaluated the efficacy, durability, and safety of UGN-102 with or without TURBT vs. TURBT alone in 282 patients with LG-IR-NMIBC. UroGen recently announced positive topline data from ATLAS and the Phase 3 ENVISION trial. The ENVISION trial evaluated the efficacy and safety of UGN-102 as a primary chemoablative therapy in 240 patients with LG-IR-NMIBC and met its primary endpoint by demonstrating that patients treated with UGN-102 had a 79.2% rate of complete response at 3-months following the initial treatment.\n\n\nThe Journal of Urology publication includes the following findings from ATLAS:\n\n\n\nTumor-free complete response 3 months after initial treatment was achieved by 92 patients (65%) who received UG...