UroGen’s Final Results from Olympus Five-Year Follow-Up Study Reinforces Durable Response with JELMYTO in Patients with Low-Grade Upper Tract Urothelial Cancer
Key Highlights
- ➤15 of 20 patients remained event-free through March 2025
- ➤No progression to high-grade disease observed during extended follow-up
- ➤Median response duration reached 47.8 months among 41 complete responders
- ➤Long-term follow-up median response duration was not estimable
- ➤JELMYTO five-year data support durable kidney-sparing treatment potential
Expert Statements
Phillip Pierorazio, Chief of Urology, Penn Presbyterian Medical Center; Professor of Surgery, Hospital of the University of Pennsylvania; lead author
“These five-year findings further demonstrate the long-term durability of response achieved with JELMYTO in adults with low-grade upper tract urothelial cancer”
Phillip Pierorazio, Chief of Urology, Penn Presbyterian Medical Center; Professor of Surgery, Hospital of the University of Pennsylvania; lead author
“The sustained disease control observed during extended follow-up provides additional evidence supporting the long-term benefits of JELMYTO.”
Mark Schoenberg, Chief Medical Officer, UroGen
“We are encouraged by the long-term clinical outcomes in patients who achieved a complete response following treatment with JELMYTO”
Mark Schoenberg, Chief Medical Officer, UroGen
“The publication of these five-year follow-up data supports JELMYTO as a kidney-sparing treatment option, providing patients with durable, long-lasting results.”
Mark Schoenberg, Chief Medical Officer, UroGen
“We look forward to pending real-world data regarding use of JELMYTO from the uTRACT Registry.”
* Five-year Olympus follow-up data published in Therapeutic Advances in Urology reinforce the long-term durability of response with JELMYTO * Results demonstrate sustained disease control through extended follow-up among patients who achieved a complete response after treatment with JELMYTO * No progression to high-grade disease was observed during extended follow-up PRINCETON, N.J., Oct. 28, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative therapies that treat urothelial and specialty cancers, today announced publication of final results from the Olympus long-term follow-up study in Therapeutic Advances in Urology, demonstrating the long-term durability of response with JELMYTO® (mitomycin) for pyelocalyceal solution in adult patients with low-grade upper tract urothelial cancer (LG-UTUC).
Among all 41 patients from the Olympus trial who achieved a complete response following primary chemoablation with JELMYTO (n=41), the median duration of response was 47.8 months, with a median follow-up of 28.1 months (95% CI: 13.1, 60.1). Twenty patients entered the long-term follow-up study with a median follow-up of 53.3 months (95% CI: 27.9, 72.8), and in these patients the median duration of response was not estimable (95% CI: 43.5, not estimable) due to the low event rate. As of March 2025, 75% (15/20) of patients in the long-term follow-up study remained event-free, and no progression to high-grade disease was observed.
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