Duration of response (DoR) following treatment with UGN-102 in patients with recurrent, low-grade, intermediate-risk, non-muscle invasive, bladder cancer: 18-month DoR data from the phase 3 ENVISION trial.

4598 Background: Low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) is a recurrent cancer inadequately controlled by the current standard of care: transurethral resection of bladder tumor (TURBT). ENVISION (NCT05243550), is an ongoing prospective, phase 3, multinational, single-arm trial, evaluating UGN-102 in patients with a history of LG-NMIBC requiring TURBT. Primary efficacy and safety results have been published previously, 1 here we report long term efficacy data with 18 months follow-up after complete response (CR) to UGN-102 at 3 months. Methods: Patients received6 weekly intravesical instillations of UGN-102, a reverse thermal hydrogel containing mitomycin (75 mg). 3 months after the first instillation of UGN-102, patients underwent cystoscopy, urine cytology testing, and for-cause biopsy, to determine the presence or absence of bladder cancer. Secondary endpoints included duration of response (DoR), defined as the time from CR at 3 months to the earliest date of disease recurrence, progression, or death from any cause, whichever occurred first. DoR data was calculated for all patients with a minimum follow-up of 18 months after 3-month CR was calculated using Kaplan–Meier (KM) method. Results: 240 patients with recurrent LG-IR-NMIBC were enrolled and received at least one dose of UGN-102; 95% (228) received all 6 doses. Patients were mainly white (98%), male (61%) and aged over 65 years old (68%). CR at 3 months was achieved by 191 patients (79.6%; 95% CI: 73.9–84.5). For these patients, the probability of remaining in response 18-months after CR was 80.6% (95% CI 74.0-85.7; KM estimate). Of those who experienced recurrence post CR, most experienced LG disease (17.3%). Conclusions: In the ENVISION study treatment with UGN-102 in patients with recurrent LG-IR-NMIBC resulted in a high and clinically meaningful CR rate. Patients who achieved an initial CR at 3 months had a high probability of remaining disease-free 18 months later. This data confirms that UGN-102 represents a valuable treatment option for patients with LG-IR-NMIBC. Clinical trial information: NCT05243550 . UGN-102 CR at 3 months (95% CI) 191/240, 79.6% (73.9–84.5) Follow-up time (months) for DoR, Median, months (95% CI)* 18.73 (18.23–20.27) DoR by Kaplan–Meier estimate at 18 months post CR 80.6% (95% CI 74.0–85.7) Patients with events at 18 months post CR 39/191 (20.4%) LG disease 33/191 (17.3%) Progression** 4/191 (2.1%) Death 2/191 (1.0%) *3-month CR patients only, estimated using reverse KM; ** Includes progression to high grade (HG) disease, T1 (Tumor Invades Lamina Propria), and Cis (Carcinoma in situ). Prasad SM et al. J Urol. 2025. 213:205–216.