- UroGen Pharma Ltd. (URGN, Financial) announced a median duration of response of two years in its OPTIMA II study for UGN-102.
- The study involved patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
- The FDA has accepted the new drug application for UGN-102, with a decision expected by June 2025.
UroGen Pharma Ltd. (URGN) has released new long-term data from the OPTIMA II Phase 2b study of its investigational drug UGN-102. The median duration of response observed in the study was 24.2 months, as per Kaplan-Meier analysis, showcasing the drug's potential in treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
The study was presented at the American Urological Association 2025 Annual Meeting in Las Vegas, underlining UGN-102's capability to offer sustained responses in a patient group where 77.8% had recurrent disease at baseline and multiple prior bladder tumor resections. Of the 41 patients achieving a complete response at three months, 17 remained in complete response during long-term follow-up.
UroGen's Chief Medical Officer, Mark Schoenberg, emphasized the urgent need for long-lasting treatment solutions and expressed optimism that UGN-102 could be a viable option for patients struggling with cancer recurrence. UroGen completed a rolling new drug application (NDA) submission to the FDA for UGN-102 in August 2024, with a Prescription Drug User Fee Act (PDUFA) target date set for June 13, 2025.
The study reported that 48.8% of patients experienced a recurrence of low-grade disease, with one progression to high-grade disease and one death due to a cardiac disorder. In total, five patients remained disease-free by the time of the four-year data analysis. The most common treatment-emergent adverse events were mild-to-moderate and included dysuria, hematuria, urinary tract infections, and fatigue.
UroGen Pharma Ltd. specializes in developing innovative cancer treatments and has utilized its proprietary RTGel® technology for UGN-102 to prolong drug exposure in the bladder, potentially providing an alternative to surgical intervention for bladder cancer patients.
