UroGen Pharma Ltd. (URGN), Monday announced 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.
Of the total 41 patients who achieved complete response at three months post-treatment with ZUSDURI, 25 remained in CR at 12 months and 17 entered the long-term follow-up study. Among those 17, the median duration of response was 3.5 years by Kaplan-Meier estimate.
Notably, these results build upon previously published 12-month DOR data, showing ZUSDURI's potential to deliver meaningful, lasting event-free periods.
Chief Medical Officer Mark Schoenberg commented, "For recurrent patients facing repeated surgeries, it offers a non-surgical approach that can empower patients and providers to choose a path that best fits individual needs and preferences."
In the pre-market hours, URGN is trading at $15.50, up 1.51 percent on the Nasdaq.
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