Data from Pharmawand - Curated by EPG Health - Date added 09 January 2019
UroGen Pharma announced topline results from the ongoing pivotal Phase III OLYMPUS clinical trial of UGN 101 (mitomycin gel) for instillation, an investigational mitomycin formulation for the non-surgical treatment of low-grade upper tract urothelial cancer (UTUC). This analysis showed that on an intent-to-treat basis, 57 percent of patients achieved a complete response (CR) rate at their primary disease evaluation (PDE, or the primary endpoint) which was conducted four to six weeks after completion of UGN 101 treatment. Importantly, all evaluated patients in CR remain disease free at six months.
The safety profile of UGN 101 continues to be acceptable with most treatment-emergent adverse events characterized as mild or moderate and transient and in line with ureteral procedures. These included ureteral narrowing and hydronephrosis, urinary tract infection, flank pain and creatinine elevation. UroGen intends to seek regulatory approval of UGN-101 in LG UTUC based on data from all 71 patients and initiated its rolling submission of the New Drug Application to the FDA 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.