UroGen Pharma announces 24-month DOR for Phase 3 ENVISION trial

UroGen Pharma (URGN) announced the 24-month duration of response, DOR, of 72.2% by Kaplan-Meier estimate in patients who achieved CR at three months from the Phase 3 ENVISION trial of ZUSDURI for intravesical solution, a treatment for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The median follow-up time after a three-month CR in this analysis was 23.7 months. The median DOR has not been reached. According to Mark Schoenberg, M.D., Chief Medical Officer, UroGen, “The 24-month duration of response data from the ENVISION trial underscore the transformative potential of ZUSDURI for adult patients with recurrent LG-IR-NMIBC. This is a population that has long endured a cycle of recurrence and repeat surgeries, a burden that weighs heavily, particularly on older adults. With ZUSDURI now approved, we have a new treatment option that can help deliver durable complete responses and meaningfully extend event-free intervals. This represents a major advance in the way we care for these patients.”