UroGen Pharma: UGN-102 showed ‘promising’ results in Phase 3 Envision trial

UroGen Pharma (URGN) announced the presentation of the Phase 3 Envision trial’s efficacy and safety results at the Society of Urologic Oncology annual meeting in Dallas, TX. These results, published online in the Journal of Urology in October, demonstrate that treatment with investigational therapy UGN-102, a mitomycin-based intravesical solution, resulted in a high and clinically meaningful complete response rate that was durable in patients with recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer. In the Envision study, UGN-102 treatment showed an impressive 82.3% duration of response at 12 months, according to the Kaplan-Meier estimate, in patients who achieved a complete response at 3 months following the initial treatment with UGN-102. The DOR at 15 months and 18 months remained robust, both at 80.9% according to the Kaplan-Meier estimates. These results build upon the trial’s positive primary endpoint, a 79.6% CR rate 3 months after the first instillation of UGN-102. The side effect profile of UGN-102 was consistent with previous clinical trials, further supporting its potential as a new treatment option for patients with LG-IR-NMIBC. The most common treatment-emergent adverse events in the Envision trial were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention. TEAEs were typically mild-to-moderate in severity and resolved or resolving. The Envision trial demonstrated a similar safety profile to that observed in other studies of UGN-102.