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UroGen Announces Positive Interim Data from Phase 2b Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer
Complete Response (CR) Rate of 65% at Three Months Of those with CR, 97% and 85% of Patients Remained Free of Disease at Six and Nine Months Follow-Up,
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n\nComplete Response (CR) Rate of 65% at Three Months\n\n\nOf those with CR, 97% and 85% of Patients Remained Free of Disease at Six and Nine Months Follow-Up, Respectively\n\n\nDetailed Results Presentation to be Shared Virtually via American Urological Association (AUA) in mid-May\n\n\n PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq:URGN) announced positive interim data analysis of UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). These data were featured in a late-breaking abstract published in the April Supplement to The Journal of Urology. The detailed results presentation will be available online via the American Urological Association (AUA) in mid-May 2020.\n\n\nThe Phase 2b OPTIMA II trial demonstrated a complete response (CR) rate at three months following onset of treatment of 65% (41/63 patients). In this subset of patients, 31/32 patients (97%) and 17/20 patients (85%) remained free of disease at six and nine months follow-up, respectively.\n\n\n“The responses we have seen demonstrate that non-surgical primary chemoablation of low-grade intermediate risk non-muscle invasive bladder cancer using UGN-102 results in a considerable treatment response with encouraging durability,” said Dr. Mark Schoenberg, Chief Medical Officer at UroGen. “There are approximately 80,000 treatable patients annually in the US, but this remains a very challenging disease with high rates of recurrence associated with currently available therapies and a need for lifelong active surveillance and repetitive surgical intervention.”\n\n\nThe most commonly reported adverse events seen to date were reported as mild to moderate and include dysuria, hematuria, urinary frequency, fatigue, urgency and urinary tract infection.\n\n\nAbout UGN-102\n\n\nUGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 2b development for the treatment of low-grade non-muscle invasive bladder cancer (LG NMIBC). Utilizing the RTGel™ Technology Platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using standard intrave...