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

Purpose:

We report the duration of response to UGN-102 treatment in patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG-IR-NMIBC) 24 months after achieving complete response (CR).

Materials and Methods:

ENVISION 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. Duration of response (from CR at 3 months to disease recurrence, progression, or death from any cause) at 24 months was estimated using the Kaplan-Meier method.

Results:

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% CI: 74-85) achieved CR. Among these responders, the probability of remaining event-free 24 months after CR was 72% (95% CI: 64-79; Kaplan-Meier estimate). Among patients with CR at 3 months (n = 191), 36 developed low-grade disease recurrence. A treatment-emergent adverse event that occurred in ≥ 10% of enrolled patients (N = 240) was dysuria.

Conclusions:

Patients who achieved CR after UGN-102 treatment had a high probability of remaining event-free 24 months later. These data indicate that 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.

Prasad, S. M., Shishkov, D., Mihaylov, N. V., Genov, P., Kates, M., Huang, W. C., Louie, M. J., Burger, B., Meads, A., Schoenberg, M., et al. (2026). 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. The Journal of Urology. Advance online publication. https://doi.org/10.1097/JU.0000000000005041