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UroGen Announces Positive Data from Pivotal OLYMPUS Trial Evaluating Jelmyto™ in Patients with Low-Grade Upper Tract Urothelial Cancer
PRINCETON, N.J.--(BUSINESS WIRE)-- UroGen Pharma Ltd. (Nasdaq:URGN) today announced the presentation of positive data from the UGN-101 (Jelmyto™ (mitomycin)
About this update from Urogen Pharma Ltd.
[{"type":"text","content":" PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq:URGN) today announced the presentation of positive data from the UGN-101 (Jelmyto™ (mitomycin) for pyelocalyceal solution) Phase 3 OLYMPUS trial in patients with low-grade upper tract urothelial cancer (LG-UTUC). The study was accepted for the 2020 American Urological Association (AUA) Annual Meeting, published as a supplement to the April 2020 issue of The Journal of Urology® and presented as part of the AUA Virtual Experience. The presentation can be accessed via the AUA website here. More information can also be accessed via UroGen’s virtual AUA experience here.\n\n\nAbout the Phase 3 OLYMPUS Trial \n\n\nOLYMPUS (Optimized DeLivery of Mitomycin for Primary UTUC Study) is an open-label, single-arm Phase 3 clinical trial of Jelmyto™ (mitomycin) for pyelocalyceal solution to evaluate the safety, tolerability and tumor ablative effect of Jelmyto in patients with low-grade upper tract urothelial cancer. The trial enrolled 74 patients at clinical sites across the U.S. and Israel. Study participants were treated with six weekly instillations of Jelmyto administered via a standard ureteral catheter. Four to six weeks following the last instillation, patients underwent a Primary Disease Evaluation (PDE) to determine complete response (CR), the primary endpoint of the study. PDE involved a ureteroscopy and wash cytology, a standard microscopic test of cells obtained from the urine to detect cancer. Patients who achieved a CR at the PDE timepoint were then followed for up to 12 months to determine the durability of response with Jelmyto.\n\n\nAbout Jelmyto™ (mitomycin) for pyelocalyceal solution\n\n\nJelmyto™ (mitomycin) for pyelocalyceal solution is a drug formulation of mitomycin for the treatment of low-grade upper tract urothelial cancer (LG-UTUC) in adult patients. Utilizing the RTGel™ technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, Jelmyto is designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. Jelmyto is delivered to patients using standard ureteral catheters or nephrostomy tube. The U.S. Food and Drug Administration granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC. Jelmyto is the fi...