(UroToday.com) The 2026 ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Sandip Prasad discussing responses to UGN-102 across EORTC recurrence score groups in patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer from the ENVISION trial.
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.1 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. The European Organization for Research and Treatment of Cancer (EORTC) recurrence score tables provide estimates of recurrence based on baseline prognostic factors. As such, Dr. Prasad and colleagues conducted a post-hoc analysis of 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 who received ≥1 dose of UGN-102. Complete response was assessed at 3 months using cystoscopy, urine cytology testing, and for-cause biopsy. Patients achieving a 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 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). Complete response rate at 3 months was 83.9%, 81.2%, and 60.0% for patients with recurrence scores of 1–4 (n = 31), 5–9 (n = 191), and 10–17 (n = 15), respectively. Of the patients with complete response at 3 months, 26.9%, 23.9%, and 33.3% (for recurrence scores of 1–4, 5–9, and 10–17) experienced recurrence of low-grade disease, progression (either in stage or grade), or death by 24 months:
The Kaplan Meier estimate of median duration of response was not estimable for any group due to the low event rates.
Dr. Prasad concluded his presentation discussing responses to UGN-102 across EORTC recurrence score groups in patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer from the ENVISION trial 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: Sandip M. Prasad, MD, MPhil, Morristown Medical Center, Atlantic Health System and Garden State Urology, Morristown, NJ
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 Society of Clinical Oncology Genitourinary (ASCO) Annual Meeting held in Chicago, IL between May 29th and June 1st, 2026
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