This morning, UroGen Pharma Ltd. released new data from an interim analysis of the ongoing pivotal Phase 3 OLYMPUS clinical trial of UGN-101 (MitoGel) for low-grade upper tract urothelial cancer (UTUC). Top-line results are expected in the third quarter of 2018.
UTUC concerns the upper urinary tract, which links the bladder to the kidney and renal pelvis. Approximately 14,500 people are living with low-grade UTUC in the United States. Currently, complete or partial surgical removal of the involved kidney and upper urinary tract is the standard of care for UTUC.
UGN-101 is delivered to patients using a standard intravesical catheter. It is a proprietary sustained release, hydrogel-based formulation. UGN-101’s design enables longer exposure of mitomycin C to the urinary tract tissue, potentially enabling the treatment of tumors by non-surgical means.
Ron Bentsur, Chief Executive Officer of UroGen, voiced his enthusiasm. “We look forward to presenting data from the OLYMPUS trial of our lead product candidate, UGN-101, for the treatment of patients with low-grade UTUC. With UGN-101, we hope to change the treatment paradigm for low-grade UTUC and potentially reduce the high recurrence rate characteristic of UTUC, while eliminating the need for surgery and the risks associated with surgery. Our goal is for UGN-101 to become the first-ever approved treatment for low-grade UTUC.”1
While enrollment for the OLYMPUS trial is ongoing, results from the interim analysis give reason to expect success. It was designed to be a single pivotal study for the approval of UGN-101 for the treatment of low-grade UTUC. The primary focus of the study is to evaluate and measure the safety, tolerability and tumor ablative effect of UGN-101 in patients with low-grade UTUC. The open-label, single-arm Phase 3 clinical trial is expected to enroll approximately 70 patients in clinical sites throughout the United States and Europe.
All study participants will be administered UGN-101 via a standard catheter in 6 weekly installations. Participants will also undergo primary disease evaluation, which will involve a ureteroscopy and wash cytology (a standard microscopic test of cells washed from the urine or bladder to detect cancer) at 4 to 6 weeks following the last treatment. Following the primary disease evaluation, all study participants will be followed for a minimum of 12 months to determine the durability of disease control with UGN-101.
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- “UroGen Pharma Announces Presentation of Results from Interim Analysis of Pivotal Phase 3 OLYMPUS Trial of UGN-101 (MitoGel™) for Non-Surgical Treatment of Upper Tract Urothelial Cancer (UTUC).” GlobeNewswire. 3, Apr. 2018