UroGen says UGN-102 met primary endpoints in both ATLAS, ENVISION trials

UroGen Pharma announced topline data from its Phase 3 trials ATLAS and ENVISION studying UGN-102 for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer. Both ATLAS and ENVISION trials met their primary endpoints. In the ATLAS trial, UGN-102 met its primary endpoint of disease-free survival, reducing risk of recurrence, progression, or death by 55%. UGN-102 also showed a 64.8% complete response rate at three months for patients who only received UGN-102, compared to a 63.6% complete response rate at three months for patients who only received a TURBT. The ENVISION trial met its primary endpoint by demonstrating that patients treated with UGN-102 had a 79.2% rate of complete response at 3-months following the initial treatment. Additional data evaluating the secondary endpoint of duration of response from ENVISION, and the submission of a New Drug Application to the U.S. Food and Drug Administration are anticipated in 2024. In both trials, UGN-102, a sustained release, hydrogel-based formulation that is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means, was generally well tolerated, with a side effect profile similar to that of previous clinical trials. The Phase 3 ATLAS clinical trial, the predecessor to ENVISION, evaluated the efficacy, durability, and safety of UGN-102 with or without TURBT vs. TURBT alone in 282 patients with LG-IR-NMIBC. ENVISION evaluated the efficacy and safety of UGN-102 as a primary chemoablative therapy in 240 patients with LG-IR-NMIBC.