UroGen has updated CR, durability data from UGN-101 Phase 3 OLYMPUS trial

UroGen Pharma announced findings from a secondary analysis from the pivotal Phase 3 OLYMPUS trial which showed that UGN-101 for instillation, an investigational mitomycin formulation, demonstrated a 59% complete response rate in a subset of patients with endoscopically unresectable low-grade upper tract urothelial cancer. The analysis showed that in the OLYMPUS intent-to-treat population, 71 patients had undergone PDE at the time of the analysis and 42 of the 71 patients achieved a CR. 41 patients entered follow-up. Of the evaluated complete responses to date, 27 patients have undergone a six-month evaluation, and 24 out of 27 patients have remained disease free at six months. Overall, 5 of 41 patients who achieved a CR have relapsed at any time during the study. Of these 71 patients, 34 were initially characterized by the treating physician as having endoscopically unresectable tumor at baseline, and 20 of 34 of these patients achieved a CR at the PDE. The most common adverse events observed were urinary tract infection, ureteral narrowing and stricture formation. The majority of ureteral events were reported as mild to moderate and have resolved. The company initiated its rolling submission of the UGN-101 New Drug Application to the U.S. Food and Drug Administration in December 2018. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC

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