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UroGen Pharma Announces Podium Presentation of Final Jelmyto® Data From Pivotal OLYMPUS Trial at the Annual Meeting of the Society of Urologic Oncology
Clinically Meaningful Response Underscores Potential for Jelmyto to Become New Standard of Care for Patients with Low-Grade Upper Tract Urothelial Cancer Of
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n\nClinically Meaningful Response Underscores Potential for Jelmyto to Become New Standard of Care for Patients with Low-Grade Upper Tract Urothelial Cancer\n\n\nOf the 58% of Patients who Achieved a Complete Response, 12-Month Durability of Response Estimated at 81.8% by Kaplan-Meier Analysis\n\n\nMedian Time to Recurrence was Not Reached\n\n\n PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN) a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced the presentation of final 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 results will be presented as a virtual podium presentation at the 21st Annual Meeting of the Society of Urologic Oncology (SUO):\n\n\nOral Session: Best of Bladder Cancer\n\n\nAbstract #: 1003\n\n\nTitle: Durability of Response to Chemoablative Treatment of Low-Grade Upper Tract Urothelial Carcinoma with a Mitomycin-Containing Reverse Thermal Hydrogel: Final Results of the OLYMPUS Trial\n\n\nPresenter: Surena F. Matin, M.D., Professor of Urology at The University of Texas MD Anderson Cancer Center in Houston, TX\n\n\nSession Date & Time: Saturday, December 5, 2020; 2:00 pm Eastern Time\n\n\nFinal results from the Phase 3 OLYMPUS trial of Jelmyto, the first and only non-surgical kidney-sparing treatment approved by the U.S. Food and Drug Administration (FDA) for adults with LG-UTUC, show that Jelmyto demonstrated clinically meaningful response in adults with LG-UTUC. In both the OLYMPUS intent-to-treat population and in the sub-population of patients who were deemed to have unresectable disease at study entry, 58% of patients achieved a complete response (CR) with durability of response at 12-months estimated to be 81.8% by Kaplan-Meier analysis. Median time to recurrence was not reached.\n\n“Current options for patients with low-grade upper tract urothelial carcinoma are not optimal. They include multiple endoscopic procedures or the removal of the kidney and ureter, both of which have consequences impacting patient health and quality of life,” said Surena F. Matin, M.D., Professor of Urology at The University of Texas MD Anderson Cancer Center in Houston, TX and Investigator of t...