UroGen Pharma announces data from OPTIMA II study of UGN-102

UroGen Pharma announced new data from the OPTIMA II study designed to obtain long-term follow-up data on UGN-102 that shows median duration of response of 24.4 months for UroGen’s investigational drug UGN-102 currently in Phase 3 development for low-grade, intermediate-risk non-muscle invasive bladder cancer. The study was presented at SUO on December 2. Patients who completed the OPTIMA II study were eligible to participate in this rollover study. Outcomes include DOR in patients who remained in complete response at the end of OPTIMA II, events of disease recurrence and progression, post-study treatments and death. At the time of data cut off, data were available for 15 of the 25 patients. The median DOR among the 15 patients was 24.4 months. Seven patients remained in CR, six patients had recurrence of LG disease, one patient had progression to high-grade disease and one patient withdrew consent but remained in CR at the last evaluation prior to discontinuation. All patients were alive at the last contact, and five patients were known to have had post-study treatment with transurethral resection of the bladder tumors or fulguration. DOR was calculated as the time from documented CR in OPTIMA II to disease recurrence or death or last adequate disease assessment. The data cut off for this report is February 25, 2022.