Introduction:
UGN-102 is a mitomycin-containing reverse thermal gel in development for primary nonsurgical chemoablative treatment of LG IR NMIBC. Final results from OPTIMA II (NCT03558503), a phase 2b clinical trial that evaluated UGN-102 for treatment of LG IR NMIBC, were previously reported. Last reported, 25 of 41 (61%) patients who achieved CR following treatment with UGN-102 remained in CR at the end of OPTIMA II (9 months after initial CR). Here, we describe interim results of an ongoing, non-interventional, rollover study to obtain long-term follow-up data in patients treated with UGN-102 in OPTIMA II.
Methods:
Patients who completed OPTIMA II are eligible to participate in this rollover study. Physicians provide updates on disease status biannually as patients continue standard of care surveillance and treatment. Outcomes of interest include duration of response (DOR) in patients who remained in complete response (CR) at the end of OPTIMA II, events of disease recurrence and progression, post-study treatments, and death. DOR was calculated as the time from first documented CR in OPTIMA II to disease recurrence or death or last adequate disease assessment (for patients who remained in CR). The data cut off date for this report is 25 Feb 2022.
Results:
At the time of the data cutoff, data were available for 15 of the 25 patients. The median (range) DOR among the 15 patients was 24.4 months (10.1 to 30.7 months). Seven patients remained in CR, 6 patients had recurrence of LG disease, 1 patient had progression to high grade disease, and 1 patient withdrew consent (no longer mobile) but remained in CR at the last evaluation prior to discontinuation. All patients were alive at the last contact, and 5 patients were known to have had post-study treatment with transurethral resection of bladder tumors (TURBT) (3 patients) or ablation (2 patients).
Data were also available for 13 patients who were non-CR at the end of OPTIMA II. Ten of these patients were known to have had post-study treatment with ablation (6 patients), TURBT (2 patients), TURBT and intravesical immunotherapy (1 patient), or adjuvant topical chemotherapy (1 patient).
Conclusion:
These data suggest continued durability in patients treated with UGN-102. Use of UGN-102 as primary chemoablative treatment in patients with LG IR NMIBC is being evaluated by the currently enrolling phase 3 ENVISION trial (NCT05243550).
Funding: UroGen Pharma
Image(s) (click to enlarge):
LONG-TERM OUTCOMES OF TREATMENT WITH UGN-102 FOR PRIMARY CHEMOABLATION OF LOW-GRADE INTERMEDIATE RISK NON-MUSCLE INVASIVE BLADDER CANCER (LG IR NMIBC)
Category
Bladder Cancer > Non-Muscle Invasive Bladder Cancer
Description
Poster #193
Friday, December 2
9:00 a.m. - 10:00 a.m.
Presented By: William C. Huang
Authors:
K. Kent Chevli
Neal D. Shore
Andrew Trainer
Daniel Saltzstein
Yaron Ehrlich
Jay D. Raman
Boris Friedman
Brian Hu
Alexander Sankin
Douglas Scherr
Matthew Nielsen
Nirmish Singla
Andrew Meads
Soumi Lahiri
Mark Schoenberg
Elyse Seltzer
William C. Huang