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The Lancet Oncology Publishes Details of UroGen Pharma’s Pivotal OLYMPUS Trial
59% Complete Response in patients with low-grade upper tract urothelial cancer Kaplan-Meier analysis, based on interim data, estimated 12-month durability at
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n\n59% Complete Response in patients with low-grade upper tract urothelial cancer\n\n\nKaplan-Meier analysis, based on interim data, estimated 12-month durability at 84% \n\n\nResults supported recent U.S. FDA expedited approval of Jelmyto™ as the first non-surgical treatment for patients with this difficult-to-treat cancer\n\n\n\n \n\n PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN) today announced The Lancet Oncology published results from the pivotal Phase 3 OLYMPUS trial, reporting that 59% of low-grade upper tract urothelial cancer (LG-UTUC) patients treated with UGN-101, now referred to as Jelmyto™ (mitomycin) for pyelocalyceal solution, achieved a Complete Response (CR). Additionally, in the publication, durability at 12 months (based on interim data) was estimated to be 84% by Kaplan-Meier analysis.1\n\n\nJelmyto consists of mitomycin, an established chemotherapy, and sterile hydrogel, using UroGen’s proprietary sustained release RTGel™ technology. It has been designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. Jelmyto is indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). It is contraindicated in patients with perforation of the bladder or upper urinary tract.\n\n\n“The current approach to treating low-grade upper tract urothelial cancer includes multiple endoscopic surgeries, high risk of disease recurrence and for many patients, the eventual removal of a kidney, which can present a whole new set of challenges that can adversely impact long-term health,” said Seth Lerner, M.D., FACS, Professor of Urology at Baylor College of Medicine in Houston, TX and Principal Investigator of the OLYMPUS trial. “Data from the OLYMPUS trial suggest UGN-101 is associated with a higher than expected initial complete response rate and strong durability without additional endoscopic surgery, which represents significant progress for patients living with this rare and difficult-to-treat type of cancer.”\n\n\nLG-UTUC is a rare cancer that develops in the lining of the upper urinary tract, ureters and kidneys. In the U.S., there are approximately 6,000 - 7,000 new or recurrent LG-UTUC patients annually. It is a challenging condition to treat due to the complex anatomy of the urinary tra...