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ASCO GU 2026: Response to Primary Chemoablation with UGN-102 in Different EORTC Risk Groups

(UroToday.com) The 2026 GU ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. William Huang discussing response to primary chemoablation with UGN-102 in different EORTC risk groups. The ENVISION phase 3 study treated patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer with UGN-102, a reverse thermal hydrogel administered intravesically containing 75 mg mitomycin.

Complete response rate at 3 months was 79.6% (95% CI 73.9, 84.5) with a 72.2% (95% CI 64.1, 78.8) probability of remaining in response 24 months later.1 The EORTC recurrence score tables provide estimates of recurrence based on baseline prognostic factors. At ASCO GU 2026, Dr. Huang and colleagues conducted a post-hoc analysis of ENVISION for complete response and duration of response by EORTC recurrence score subgroup.

There were 240 patients with recurrent low grade intermediate risk non muscle invasive bladder cancer that received ≥1 dose of UGN-102 in ENVISION. Complete response was assessed at 3 months using cystoscopy, urine cytology testing, and for-cause biopsy. Patients achieving complete response entered the follow-up period and are being assessed for recurrence or progression for up to 5 years:

There were 240 patients with recurrent low grade intermediate risk non muscle invasive bladder cancer that received ≥1 dose of UGN-102 in ENVISION. Complete response was assessed at 3 months using cystoscopy, urine cytology testing, and for-cause biopsy. Patients achieving complete response entered the follow-up period and are being assessed for recurrence or progression for up to 5 years: 

Complete response at 3 months and probability of maintaining complete response at 24 months duration of response in patients with EORTC recurrence scores of 1-4, 5-9, and 10-17 were calculated. Duration of response was calculated using the Kaplan–Meier estimation method.

The median EORTC recurrence score was 7 (range: 2-13), including 31 patients with EORTC score 1-4, 191 patients with EORTC score 5-9, and 15 patients with EORTC score 10-17:

The median EORTC recurrence score was 7 (range: 2-13), including 31 patients with EORTC score 1-4, 191 patients with EORTC score 5-9, and 15 patients with EORTC score 10-17: 

Complete response rate at 3 months was 83.9%, 81.2%, and 60% for patients with recurrence scores of 1-4, 5-9, and 10-17, respectively:

Complete response rate at 3 months was 83.9%, 81.2%, and 60% for patients with recurrence scores of 1-4, 5-9, and 10-17, respectively: 

The probability of remaining event-free at 24 months was 67.4%, 73.7%, and 66.7% for patients with EORTC scores 1-4, 5-9, and 10-17, respectively:

The probability of remaining event-free at 24 months was 67.4%, 73.7%, and 66.7% for patients with EORTC scores 1-4, 5-9, and 10-17, respectively: 

The Kaplan–Meier estimate of median duration of response was not estimable for any group due to the low event rates.

Dr. Huang concluded his presentation discussing response to primary chemoablation with UGN-102 in different EORTC risk groups with the following take-home points:

  • UGN-102 demonstrated robust complete response rates across all EORTC recurrence score subgroups, including patients with higher baseline recurrence risk
  • The majority of patients remained recurrence-free at 24 months
  • Despite the post-hoc design and small subgroup sizes, these findings suggest UGN-102 provides durable and clinically meaningful disease control in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer

Presented by: William Huang, MD, New York University, New York, 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 2026 Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, CA, Thurs, Feb 26 – Sat, Feb 28, 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.