UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On December 3, 2020, UroGen Pharma Ltd. announced 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).
Final 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 with durability of response at 12-months estimated to be 81.8% by Kaplan-Meier analysis. Median time to recurrence was not reached.
The safety profile in the final OLYMPUS data was consistent with previously reported results. The most common adverse events were uretic stenosis, urinary tract infection, hematuria, flank pain, nausea, dysuria, renal dysfunction, abdominal pain and vomiting.
OLYMPUS (Optimized DeLiverY of Mitomycin for Primary UTUC Study) is an open-label, single-arm Phase 3 clinical trial of UGN-101, Jelmyto (mitomycin) for pyelocalyceal solution, to evaluate the safety, tolerability and tumor ablative effect of Jelmyto in patients with low-grade UTUC. Seventy-one patients were treated at clinical sites across the United States and Israel. Study participants were treated with six weekly instillations of Jelmyto administered via a standard 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 and for cause biopsy. Patients who achieved a CR at the PDE timepoint were continued onto the maintenance phase of the trial, during which they were to receive monthly maintenance instillations for up to 12 months to determine the durability of response with Jelmyto.
| Item 9.01 | Financial Statements and Exhibits. |
(d)
| Exhibit |
Description | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: December 3, 2020 | UROGEN PHARMA LTD. | |||||
| By: | /s/ Molly Henderson | |||||
| Molly Henderson | ||||||
| Chief Financial Officer | ||||||