(UroToday.com) The 2025 ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Sandip Prasad discussing 18-month data from the phase 3 ENVISION trial assessing duration of response following 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. ENVISION is an ongoing, prospective, phase 3, multinational, single-arm trial, evaluating UGN-102 in patients with a history of low-grade, non-muscle invasive bladder cancer requiring TURBT. Primary efficacy and safety results have been published previously,1 and at the ASCO 2025 annual meeting, Dr. Prasad reported long term efficacy data with 18 months follow-up after complete response to UGN-102 at 3 months.
Patients received 6 weekly intravesical instillations of UGN-102, a reverse thermal hydrogel containing mitomycin (75 mg). Three months after the first instillation of UGN-102, patients underwent cystoscopy, urine cytology testing, and for-cause biopsy to determine the presence or absence of bladder cancer:
Secondary endpoints included duration of response, defined as the time from complete response at 3 months to the earliest date of disease recurrence, progression, or death from any cause, whichever occurred first. Duration of response data was calculated for all patients with a minimum follow-up of 18 months, after 3-month complete response was calculated using Kaplan–Meier method.
There were 240 patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer enrolled and received at least one dose of UGN-102; 95% (228) received all 6 doses of treatment. Patients were mainly white (98%), male (61%), and aged over 65 years old (68%):
Complete response at 3 months was achieved by 191 patients (79.6%; 95% CI: 73.9–84.5). For these patients, the probability of remaining in response 18-months after complete response was 80.6% (95% CI 74.0-85.7 by Kaplan–Meier estimate):
For the key secondary endpoint of duration of response, the median was not estimable over a median follow-up of 18.7 months due to the paucity of disease recurrence. Of those who experienced recurrence post complete response, most experienced low-grade disease (17.3%).
Dr. Prasad concluded his presentation discussing 18-month data from the phase 3 ENVISION trial assessing duration of response following 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 using UGN-102 results in a high and clinically meaningful complete response rate in patients with recurrent low grade non muscle invasive bladder cancer
- Furthermore, the durability of the effect is robust, with trial participants who achieved an initial complete response at 3 months having an 80.6% probability of remaining disease free 18 months later
- These observations provide further evidence that UGN-102 may represent a well tolerated and efficacious treatment option for patients with low grade non muscle invasive bladder cancer
- UGN-102 would potentially be the first approved medical therapy for this condition
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 (ASCO) 2025 Annual Meeting, Chicago, IL, Fri, May 30 – Tues, Jun 3, 2025.
References:
- 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.