65% Complete Response Rate at Three Months
Duration of Response Estimated to be 72.5% at Nine Months (12-Months from Initiation of Therapy) by Kaplan-Meier Method; Median Duration of Response was Not Reached
Treatment with UGN-102 was Generally Well Tolerated, with Mostly Mild to Moderate Adverse Events Reported
Phase 3 Pivotal Trial Evaluating UGN-102 Versus Current Standard of Care Expected to Start by Year-End
#URGN "announced final topline results from the single-arm, open-label OPTIMA II Phase 2b trial evaluating the efficacy and safety of investigational UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). As previously reported, 65% (41/63) of patients receiving UGN-102 achieved a complete response (CR) three months after the start of therapy. In this subset of patients, duration of response at nine months (12-months from start of therapy) was estimated by Kaplan-Meier analysis to be 72.5%. Median duration of response was not reached. The Company expects to initiate a Phase 3 study evaluating UGN-102 versus current standard of care by the end of the year.
Treatment with UGN-102 was generally well tolerated and the safety profile was consistent with previously reported results. In the OPTIMA II trial, the majority of the most common adverse events (≥ 10%) were reported as mild to moderate in severity and include dysuria, urinary frequency, hematuria, urinary urgency, urinary tract infection and fatigue. No treatment related serious adverse events were reported.
Patients with LG IR-NMIBC are chronically relapsing and currently, their only treatment option is repeated transurethral resection of bladder tumors (TURBT). Some patients require multiple TURBT surgeries per year, which can lead to increased morbidity and risks associated with repetitive anesthesia. It is estimated that 80,000 people in the U.S. are treated annually for LG IR-NMIBC. This includes newly diagnosed patients and patients who have a recurrence after surgery.
The Company anticipates submitting the data for presentation at an upcoming medical meeting as well as potential publication in a peer-reviewed journal" (see press release HERE).
See our URGN #UGN-102 AmpCard HERE.