UroGen Pharma announces five-year long-term extension study of ZUSDURI

UroGen Pharma (URGN) announced the publication of results of a five-year long-term extension study of the Phase 2b OPTIMA II trial evaluating ZUSDURI for intravesical solution in patients with low-grade intermediate-risk non-muscle invasive bladder cancer demonstrating durable, long-term complete responses, CR, in patients who initially achieved a CR following treatment with ZUSDURI. The publication, titled “Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer With UGN-102: Outcomes From the 5-year Long-Term Extension Study of the Single-Arm, Phase 2b OPTIMA II Study.” Among the 41 patients who achieved CR at three months post-treatment with ZUSDURI in the OPTIMA II trial, 25 remained in CR at 12 months and 17 entered the long-term follow-up study. For the 41 patients achieving CR at three months, the median Kaplan-Meier estimate of duration of response, DOR, was 24.2 months with a median follow-up of 35.8 months. For the 17 patients in the long-term follow-up study, the median DOR was 42.1 months by Kaplan-Meier estimate, with a median follow-up of 50.4 months. These results build upon previously published 12-month DOR data, showing ZUSDURI’s potential to deliver meaningful, lasting event-free periods.