Introduction:
UGN-102 is a mitomycin-containing reverse thermal gel in development for primary nonsurgical treatment of LG IR NMIBC. Patients with LG NMIBC are currently treated with transurethral resection of bladder tumors (TURBT), usually under general anesthesia. There is no approved medicinal product for primary treatment. A subset of patients with LG NMIBC (IR population) experience repeated recurrence of tumors requiring repetitive TURBT, which is associated with postoperative and long-term morbidity and an increased mortality risk.
This Phase 3 study is designed to confirm the results of a Phase 2b single-arm study in patients with LG IR NMIBC, in which 41/63 (65%) patients achieved the primary endpoint of complete response (CR) and 25/41 (61%) patients had a durable CR (DCR) at 12 months after the start of treatment. The probability of durable response 9 months after CR was estimated to be 73% by Kaplan-Meier analysis (Chevli et al. J Urol. 2022;207(1):61-69).
Methods:
Approximately 220 patients with a history of LG NMIBC and prior TURBT who meet IR disease criteria will receive 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin). Response will be assessed by cystoscopy, histopathology (if applicable), and urine cytology every 3 months (every 6 months after 2 years). Non-CR patients at 3 months will undergo standard of care (SOC) treatment and then enter follow-up. Patients with disease recurrence or progression during follow-up will undergo SOC treatment and then end-of-study procedures 3 months later.
The primary endpoint is CR rate at 3 months after the start of treatment. Secondary endpoints include duration of response (DOR) (key secondary), DCR rate at scheduled disease assessment time points, disease-free survival (DFS), and safety/tolerability. Point estimates of CR and DCR rates with exact 95% confidence intervals will be summarized. DOR and DFS will be estimated using the Kaplan‑Meier method.
This study is recruiting (NCT05243550).
Results:
Conclusion:
Funding: UroGen Pharma
Image(s) (click to enlarge):
A PHASE 3 SINGLE-ARM STUDY OF UGN-102 AS PRIMARY CHEMOABLATIVE THERAPY IN PATIENTS WITH LOW GRADE INTERMEDIATE RISK NON-MUSCLE INVASIVE BLADDER CANCER (LG IR NMIBC)
Category
Bladder Cancer > Non-Muscle Invasive Bladder Cancer
Description
Poster #184
Friday, December 2
9:00 a.m. - 10:00 a.m.
Presented By: Christine E. Lentowski
Authors:
Christine E. Lentowski
Soumi Lahiri
Mark Schoenberg
Elyse Seltzer
ENVISION Study Group
William C. Huang
Sandip M. Prasad