A 24-month follow-up of UGN-102, a nonsurgical treatment for low-grade intermediate-risk non-muscle invasive bladder cancer, showed that the treatment can provide a long-term complete response for patients. The results were recently published in the Journal of Urology.
Findings were based on a 24-month analysis of the Phase 3 ENVISION clinical trial, which included 240 individuals. Of the 191 participants who achieved a complete response after three months, an estimated 72% were event-free at 24 months.
UGN-102 is a hydrogel that contains mitomycin, which is an antitumor antibiotic that damages DNA to slow the growth of cancer cells. Providers administer the drug as a liquid via urinary catheter into the bladder, where it converts to a gel.
Among the 49 individuals with a noncomplete response at three months, 15% had residual disease and 2.5% experienced disease progression. The remaining patients either had missing data or an indeterminate response.
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While the investigators reported five deaths in patients with complete response at three months, none were related to treatment.
In exploratory analyses, a predicted 78% of those who had one or fewer transurethral resection of bladder tumor (TURBT) procedures remained event-free at two years. Conversely, a predicted 61% of those receiving more than one TURBT remained event-free in the same time frame.
In addition, the probability of remaining event-free at two years did not differ by number of tumors.
The most common side effects were discomfort during urination (23%), blood in the urine (8.3%) and urinary tract infection (7.1%). In total, 146 participants reported an adverse event, with 39 of those events being serious.
“These data indicate that UGN-102 is a nonsurgical treatment that provides a durable complete response for patients with recurrent LG-IR-NMIBC [low-grade intermediate-risk non-muscle invasive bladder cancer], addressing a critical unmet need in this population,” the researchers concluded.
The U.S. Food and Drug Administration approved UGN-102 for this patient population in June 2025.
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