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UroGen Pharma Announces First Presentation of Data from Phase 2b Study of UGN-102 in Patients with Difficult to Treat Type of Bladder Cancer
65% Complete Response in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer Of Patients who Achieved a Complete Response and
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n\n65% Complete Response in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer\n\n\nOf Patients who Achieved a Complete Response and Underwent an Evaluation at Each Timepoint, 97%, 86% and 85% Remained Disease Free at Six, Nine and 12 Months Following Initiation of Therapy, Respectively\n\n\nPositive Data Continue to Validate UroGen’s Proprietary Technology Platform and Value of Intravesical Therapy Dwell Time\n\n\nAmerican Urological Association Abstract Presentations Available Online In Lieu of Annual Meeting\n\n\n PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN) today announced the presentation of positive interim data from the Phase 2b OPTIMA II trial evaluating the safety and efficacy of investigational agent UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). The study was accepted for the 2020 American Urological Association (AUA) Annual Meeting, published as a supplement to the April 2020 issue of The Journal of Urology® and presented as part of the AUA Virtual Experience. The presentation can be accessed via the AUA website here.\n\n\nTrial results showed that 65% (41/63) of patients treated with UGN-102 achieved a complete response (CR) three months after the start of therapy. In this subset of patients, 97% (35/36) of patients (95% Confidence Interval), 86% (24/28) of patients and 85% (11/13) of patients who were present for evaluation at each timepoint, remained disease free at six, nine and 12 months following treatment initiation, respectively. Follow-up will continue until all patients have reached the 12-month time point.\n\n\n“With UGN-102, we have an opportunity to fundamentally change the way low-grade intermediate risk non-muscle invasive bladder cancer is treated and help patients avoid recurrence of their cancer and repetitive surgeries,” said Dr. Mark Schoenberg, Chief Medical Officer at UroGen. “The positive data presented today, coupled with previously presented data in low-grade upper tract urothelial cancer, continue to validate our technology platform and our hypothesis that increased dwell time significantly improves the effectiveness of intravesical therapy.”\n\n\nNon-Muscle Invasive Bladder Cancer (NMIBC) is stratified into three risk categories: low, intermediate...