UGN-102 for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer: 24-Month Duration of Response Results From the Phase 3 ENVISION Trial.

Abstract

To report the duration of response (DoR) to UGN-102 treatment in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) 24 months after achieving complete response (CR). ENVISION (NCT05243550) is an ongoing, multinational, single-arm, phase 3 study in patients with biopsy-proven recurrent LG-IR-NMIBC. Patients received 6 once-weekly intravesical instillations of UGN-102. Patients underwent cystoscopy, urine cytology testing, and for-cause biopsy to determine bladder cancer presence at 3 months. DoR (from CR at 3 months to disease recurrence, progression, or death from any cause) at 24 months was estimated using the Kaplan-Meier (KM) method. A total of 240 patients were enrolled and received ≥1 dose of UGN-102. Most patients were White (98%), male (61%), and aged ≥65 years (68%). At 3 months, 191 patients (80%; 95% confidence interval [CI]: 74, 85) achieved CR. Among these responders, the probability of remaining event-free 24 months after CR was 72% (95% CI: 64, 79; KM estimate). Among patients with CR at 3 months (n = 191), 36 developed LG disease recurrence. Treatment-emergent adverse events that occurred in ≥10% of enrolled patients (N = 240) was dysuria. Patients who achieved CR following UGN-102 treatment had a high probability of remaining event-free 24 months later. These data indicate UGN-102 is a novel, nonsurgical treatment that provides a durable CR for patients with recurrent LG-IR-NMIBC. Study limitations included the single-arm design and the limited racial diversity of the patients.