SES AUA 2026: UGN-102 for Low-Grade Intermediate Risk Non Muscle Invasive Bladder Cancer: 5-Year Long-Term Extension Study Results from the Single-Arm, Phase 2B OPTIMA II Study

(UroToday.com) The 2026 SESAUA annual meeting featured a bladder cancer session and presentation by Dr. William Huang discussing long-term results from the single-arm, phase 2 OPTIMA II study assessing UGN-102 for low-grade intermediate risk non-muscle invasive bladder cancer. The OPTIMA II phase 2b study treated patients with low-grade intermediate risk non-muscle invasive bladder cancer with UGN-102, a reverse thermal hydrogel containing mitomycin.¹ Twelve-month primary efficacy and safety results were previously reported, and at the 2025 SESAUA annual meeting, Dr. Huang and colleagues reported the 5-year follow-up data.

Patients who participated in OPTIMA II and achieved a complete response at 3 months, after 6 once-weekly intravesical doses of UGN-102, were followed for up to 9 months after the initial complete response. Those with a complete response at study completion were eligible to enroll in an observational long-term follow-up study, which did not require protocol-specified interventions or visits. Supervising physicians provided semi-annual updates on a patient’s disease status. The outcomes included disease recurrence or progression and duration of response, which was calculated using the Kaplan–Meier method.

In total, 63 patients with a mean age of 70.5 (SD 11.7) years were enrolled and treated in OPTIMA II. Overall, 87.3% of patients were Caucasian, and 60.3% were male. Most patients (77.8%) had recurrent disease at baseline with multiple prior TURBT procedures:
Of the 41 patients with complete response at 3 months, 25 remained disease-free at 12 months, and 17 entered long-term follow-up. For the 41 patients with complete response at 3 months, the median duration of response was 24.2 months (95% CI 9.7, 42.1), with a median follow-up time of 35.8 months (95% CI 10.8, 61.0):

Of the 41 patients with complete response at 3 months, 25 remained disease-free at 12 months, and 17 entered long-term follow-up. For the 41 patients with complete response at 3 months, the median duration of response was 24.2 months (95% CI 9.7, 42.1), with a median follow-up time of 35.8 months (95% CI 10.8, 61.0):
For the 17 long-term follow-up patients, median duration of response was 42.1 months (95% CI 24.2, not estimable), with a median follow-up of 50.4 months (95% CI 27.0, not estimable):

For the 17 long-term follow-up patients, median duration of response was 42.1 months (95% CI 24.2, not estimable), with a median follow-up of 50.4 months (95% CI 27.0, not estimable):

Dr. Huang concluded his presentation discussing long-term results from the single-arm, phase 2 OPTIMA II study with the following take-home points:

UGN-102 results in clinically meaningful and highly durable complete responses in patients with low-grade intermediate-risk non-muscle invasive bladder cancer
UGN-102 may represent an efficacious non-surgical alternative to TURBT for low-grade intermediate-risk non-muscle invasive bladder cancer patients

Presented by: William Huang, MD, Professor, Departments of Urology and Radiology, Vice Chair, Clinical Affairs, Co-Director, Robotics Program, NYU Langone, 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 Southeastern Section of the American Urological Association (SESAUA) Annual Meeting, San Juan, PR, Wed, Mar 18 – Sat, Mar 21, 2026.

Reference:

Shore ND, Chevli KK, Saltzstein D, et al. Non-Muscle Invasive Bladder Cancer with UGN-102: Outcomes From the 5-Year Long-Term Extension Study of the Single-Arm, Phase 2b Optima II Study. Clin Genitourin Cancer. 2025 Oct;25(5):e1-e8.

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