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The Journal of Urology Publishes Results of UroGen Pharma’s Phase 2b Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (LG IR-NMIBC)
Clinically Meaningful Response and Sustained Durability Underscore Potential for UGN-102 to Become a Non-Surgical Primary Therapeutic Treatment for Patients
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n\nClinically Meaningful Response and Sustained Durability Underscore Potential for UGN-102 to Become a Non-Surgical Primary Therapeutic Treatment for Patients with Highly Recurrent LG IR-NMIBC \n\n\n65% Complete Response (CR) Rate at Three Months\n\n\n61% of Patients Remain in CR at 12 Months\n\n\n\n\nData Supports Ongoing Phase 3 Development of UGN-102 in LG IR-NMIBC as an Alternative to Surgery\n\n\n PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN) today announced The Journal of Urology® published results from the Phase 2b OPTIMA II trial, a Phase 2b, open-label, single-arm trial studying UGN-102 (mitomycin) for intravesical solution as primary non-surgical therapy for low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). The study was published online and will be in the January print edition of The Journal of Urology®.\n\nApproximately 50-60% of the 81,000 estimated new cases of non-muscle invasive bladder cancer (NMIBC) diagnosed in the U.S. in 2020 were low-grade. Patients with LG IR-NMIBC are chronically relapsing, and their only treatment option is repeated transurethral resection of bladder tumor (TURBT) with or without adjuvant chemotherapy. Some patients require multiple TURBT surgeries per year, which may lead to post-operative and long-term morbidity for this patient population.\n\nThe OPTIMA II Phase 2b results showed a significant treatment response with sustained durability in non-surgical chemoablation of LG IR-NMIBC. As previously reported, 65% (41/63) of patients receiving UGN-102 achieved a complete response (CR) three months after the start of therapy, of whom 39 (95%), 30 (73%), and 25 (61%) remained disease-free at 6, 9, and 12 months after treatment initiation, respectively. The probability of durable response nine months after CR (12 months after treatment initiation) was estimated to be 72.5% by Kaplan-Meier analysis. Thirteen patients had documented recurrences. 57 of 63 (90%) patients completed all 6 instillations of UGN-102 according to study protocol.\n\n“The data from the OPTIMA II trial represent a significant advancement in the development of UGN-102 for the treatment of LG IR-NMIBC and further support the contention that non-surgical therapy for this disease is both technically feasible and clinically meaningful,” said Dr. Mark Schoenberg, Chief Medi...