Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer With UGN-102: Outcomes From the 5-Year Long-Term Extension Study of the Single-Arm, Phase 2b Optima II Study

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– 248/250 words Introduction The OPTIMA II phase 2b study (NCT03558503) treated patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) with UGN-102, a reverse thermal hydrogel containing mitomycin. Efficacy and safety results have been reported for the 12-month parent study; here, we report 5-year follow-up data. Patients and Methods Patients who participated in the OPTIMA II study and achieved a complete response (CR) after 6 weekly doses of UGN-102 were followed for up to 9 months after initial CR. Those with CR at study completion were eligible to enroll in a further long-term follow-up (LTFU) study, during which there were no protocol-specified interventions/treatments, protocol-specified visits, or evaluations. Supervising physicians provided semiannual updates on patients' disease status. Duration of response (DoR) was calculated using the Kaplan–Meier method. Results Of the 41 patients achieving a CR at 3 months, 25 remained in CR at 12 months and 17 entered LTFU. For the 41 patients achieving a CR at 3 months the median Kaplan–Meier estimate of DoR was 24.2 months (95% confidence interval [CI] 9.72, 42.09), with a median follow-up time of 35.8 months (95% CI 10.78, 60.98). For the 17 patients in the LTFU study the median DoR was 42.1 months (95% CI 24.18, not estimable [NE]), with a median follow-up of 50.40 months (95% CI 26.97, NE), Conclusion These results demonstrate that treatment with UGN-102 results in clinically meaningful, and highly durable response in patients with LG-IR-NMIBC. UGN-102 may offer a promising non-surgical alternative to TURBT for LG-IR-NMIBC patients. Micro abstract 60/60 words: A 5-year follow-up study of patients who achieved a complete response in the OPTIMA II trial after 6 weekly doses of UGN-102 is described. The 17 enrolled patients had a median Kaplan–Meier estimate of duration of response of 42.1 months (95% confidence interval [CI] 24.18, not estimable [NE]), with a median follow-up of 50.4 months (95% CI 26.97, NE).

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