- UroGen Pharma Ltd. (URGN, Financial) reports an 80.6% 18-month Duration of Response (DOR) from the Phase 3 ENVISION trial for UGN-102.
- The investigational treatment targets recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC).
- The trial data was presented at the American Urological Association 2025 Annual Meeting in Las Vegas.
UroGen Pharma Ltd. (URGN), a biotech company specializing in urothelial and specialty cancers, announced an impressive 80.6% 18-month Duration of Response (DOR) from its Phase 3 ENVISION trial of UGN-102, an investigational treatment designed for recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC). This data was disclosed during a presentation at the American Urological Association (AUA) 2025 Annual Meeting held in Las Vegas, Nevada.
According to Sandip Prasad M.D., M.Phil., significant outcomes were observed where patients achieved complete response (CR) at three months, with 79.6% of participants showing positive results. The data underlines the potential of UGN-102 in reducing the recurrence of low-grade bladder cancer, which is traditionally treated with repeated invasive surgeries like transurethral resection of bladder tumor (TURBT). These surgeries can be particularly burdensome for patients, especially the elderly, making non-surgical options a high priority.
UroGen completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UGN-102, with a Prescription Drug User Fee Act (PDUFA) goal date set for June 13, 2025. If approved, UGN-102 could significantly shift treatment paradigms by offering durable complete responses and reducing the need for frequent surgical interventions.
The safety profile of UGN-102 was comparable to previous studies, with common treatment-emergent adverse events (TEAEs) such as dysuria, hematuria, and urinary tract infection, generally mild to moderate in severity. The promising trial outcomes contribute to the growing evidence supporting UGN-102’s potential as a chemoablative therapy, delivered through UroGen’s proprietary RTGel® technology.
