UroGen Pharma announces long-term follow up data from OPTIMA II Phase 2b study

UroGen Pharma (URGN) announced new data from the OPTIMA II Phase 2b study of UGN-102 for intravesical solution demonstrate clinically meaningful two-year duration of response by Kaplan-Meier analysis. UGN-102 is UroGen’s sustained-release formulation of mitomycin being developed for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The majority of patients included in OPTIMA II had recurrent disease at baseline, with multiple prior transurethral resection of bladder tumor procedures. Among the 41 patients achieving a complete response at three months, 25 remained in CR at 12 months, and 17 of these patients entered long-term follow-up. The median Kaplan-Meier estimate of duration of response for the 41 patients that achieved CR was 24.2 months, with a median follow-up time of 33.6 months. Twenty patients experienced recurrence of low-grade disease. One patient progressed to high-grade disease and one patient died due to a cardiac disorder. Five patients remained disease-free at the time of the four-year data analysis.