UroGen Pharma reports ENVISION results to be published in The Journal of Urology

UroGen Pharma (URGN) announced that the three-month complete response rate and 12-month durability of response from the Phase 3 ENVISION study of investigational drug UGN-102 in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer were published in the February issue of The Journal of Urology. In the ENVISION trial, UGN-102 treatment demonstrated an impressive 82.3% 12-month duration of response by Kaplan-Meier estimate in patients who achieved a CR at three months after the first instillation of UGN-102 for intravesical solution. The Kaplan-Meier estimates for DOR at 15 months and 18 months following the three-month CR were both 80.9%. The ENVISION trial also met its primary endpoint, showing a 79.6% CR rate at three months in patients treated with UGN-102. UroGen initiated the submission of a rolling new drug application to the FDA for UGN-102 as a treatment for LG-IR-NMIBC in January 2024 and completed the NDA submission in August, ahead of schedule. The FDA accepted the NDA for UGN-102 with a PDUFA goal date of June 13. The most common treatment-emergent adverse events in the ENVISION trial were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention. The TEAEs were typically mild-to-moderate in severity and either resolved or were resolving. The ENVISION trial demonstrated a similar safety profile to that observed in other studies of UGN-102.