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AUA 2026: Treatment with UGN-102 in Patients with Recurrent Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer: 24-Month Duration of Response Data from the Phase 3 ENVISION Trial

(UroToday.com) The 2026 American Urological Association annual meeting featured a non-invasive bladder cancer session and a presentation by Dr. Mark Schoenberg discussing 24-month duration of response data from the phase 3 ENVISION trial assessing treatment with UGN-102 in patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer.

  • Low-grade intermediate risk non-muscle invasive bladder cancer is a recurrent cancer inadequately controlled by the current standard of care: TURBT with or without postoperative intravesical chemotherapy. ENVISION is an ongoing pivotal, prospective, phase 3, multinational, single-arm trial evaluating UGN-102, a reverse thermal hydrogel containing mitomycin (75 mg), in patients with a history of low-grade non-muscle invasive bladder cancer requiring TURBT. The primary results have been published previously.1 At the AUA 2026 annual meeting, Dr. Schoenberg and colleagues reported long-term durability data 24 months after a 3-month complete response to UGN-102.

Patients received 6 once-weekly intravesical instillations of UGN-102, which contains mitomycin (75 mg). Approximately 3 months after the first instillation, patients underwent cystoscopy, urine cytology testing, and for-cause biopsy to evaluate for bladder cancer presence. Duration of response (time from complete response at 3 months to the earliest date of disease recurrence, progression, or death from any cause, whichever occurred first) at 12 and 24 months after complete response was calculated using Kaplan Meier estimate with Brookmeyer–Crowley confidence intervals. The median duration of response was estimated with a Weibull model. The study design for ENVISION is as follows: 

There were 240 patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer enrolled and received ≥1 dose of UGN-102; 95% (228) of patients received all 6 doses. Patients were mainly White (98%), male (61%), and aged ≥65 years (68%). Complete response at 3 months was achieved by 191 patients (79.6%; 95% CI 73.9 - 84.5). Among the 49 patients with no clinical response (20.4%, n = 49), this included 36 with residual disease, 6 with progression, 2 indeterminate, and 5 with missing data:

 There were 240 patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer enrolled and received ≥1 dose of UGN-102; 95% (228) of patients received all 6 doses. Patients were mainly White (98%), male (61%), and aged ≥65 years (68%). Complete response at 3 months was achieved by 191 patients (79.6%; 95% CI 73.9 - 84.5). Among the 49 patients with no clinical response (20.4%, n = 49), this included 36 with residual disease, 6 with progression, 2 indeterminate, and 5 with missing data: 

For 3-month complete response patients, the probability of remaining in response 12 and 24 months after complete response was 82.4% (95% CI: 76.0 - 87.2; number at risk: 145) and 72.2% (95% CI: 64.1 - 78.8; number at risk: 41), respectively: 

 For 3-month complete response patients, the probability of remaining in response 12 and 24 months after complete response was 82.4% (95% CI: 76.0 - 87.2; number at risk: 145) and 72.2% (95% CI: 64.1 - 78.8; number at risk: 41), respectively:  

Over a median follow-up time of 23.7 months (95% CI 23.7 - 23.9), the event rate in patients who achieved a complete response remained stable through 24 months after complete response. The following tables summarize the adverse events noted in the ENVISION trial: 

Over a median follow-up time of 23.7 months (95% CI 23.7 - 23.9), the event rate in patients who achieved a complete response remained stable through 24 months after complete response. The following tables summarize the adverse events noted in the ENVISION trial: 

Dr. Schoenberg concluded his presentation discussing a 24-month duration of response data from the phase 3 ENVISION trial assessing treatment with UGN-102 in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer with the following take-home points:

  • Results from ENVISION demonstrate that treatment with UGN-102 results in a robust and clinically meaningful complete response rate (79.6%) in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer
  • Trial participants who achieved an initial complete response had a high probability, per the Kaplan Meier estimation method, of remaining event-free 12 and 24 months later: 82.4% and 72.2%, respectively

 The following information reports the duration of response from the 3-month complete  response population (n = 191), which is different from the USPI efficacy population (n =  173)

  • Limitations of the current study include its single-arm design, which requires caution when interpreting outcomes without a concurrent control group
  • UGN-102 is a valuable nonsurgical option for the treatment of patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, with demonstrable durability and tolerability

Presented by: Mark Schoenberg, MD, Urologist, Montefiore Einstein, Bronx, NY

Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the American Urological Association (AUA) 2026 Annual Meeting, Washington, DC, Fri, May 15 – Mon, May 18, 2026. 

Reference:

  1. Prasad SM, Shishkov D, Vladimirov Mihaylov N, et al. Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer with UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION). J Urol. 2025 Feb;213(2):205-216.