UroGen Pharma Ltd. has announced the publication of results from a five-year long-term extension study of the Phase 2b OPTIMA II trial. The study evaluated ZUSDURI (mitomycin) as an intravesical solution for patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The findings, now available in the journal Clinical Genitourinary Cancer, demonstrate durable, long-term complete responses in patients who initially achieved a complete response following treatment with ZUSDURI. Patients remained event-free for a median of two years post-treatment, with a median duration of response of 3.5 years, according to Kaplan-Meier estimates. The study included both newly diagnosed and recurrent patients, with the majority being recurrent cases. Safety data from the long-term follow-up trial were not collected, but treatment emergent adverse events from the original OPTIMA II study were noted.
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