UroGen Pharma Touts Four-Year Response With Urothelial Cancer Drug Study, Highlights Potential For Bladder Cancer Candidates

Core Insights - UroGen Pharma Ltd. reported a nearly four-year duration of response from a long-term follow-up study with Jelmyto for low-grade upper tract urothelial cancer [1] - The FDA approved Jelmyto in 2020 for treating low-grade upper tract urothelial cancer in adults [1] Group 1: Jelmyto (mitomycin) for LG-UTUC - In the OLYMPUS trial, patients who achieved a complete response had a median duration of response of 47.8 months, with a median follow-up of 28.1 months [2] - Among the 41 patients, 21 had new-onset UTUC and 20 had recurrent UTUC, with no significant differences in durability between the groups [2] - A total of 20 patients entered long-term follow-up, and the Jelmyto uTRACT Registry is enrolling participants to gather real-world usage data [3] Group 2: UGN-102 (mitomycin) for LG-IR-NMIBC - The OPTIMA II Phase 2b study showed a clinically meaningful two-year duration of response of 24.2 months for UGN-102 [4] - Among 41 patients achieving a complete response at three months, 25 remained in complete response at 12 months [4] - The median duration of response for these patients was 24.2 months, with 48.8% experiencing recurrence of low-grade disease [5] Group 3: Regulatory and Safety Updates - UroGen completed the submission of the UGN-102 rolling new drug application to the FDA in August 2024, with a PDUFA goal date of June 13, 2025 [6] - Safety data from the Phase 1 dose-escalation study for UGN-301 indicated no dose-limiting toxicities or treatment-emergent adverse events leading to discontinuation [7][8] - At the 15-month disease assessment, 60% of patients with Ta/T1 disease treated with 300 mg remained recurrence-free [9] Group 4: Market Reaction - UroGen's stock price increased by 7.65% to $10.63 following the announcements [10]