Patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG-IR-NMIBC) who achieved an initial complete response (CR) to UGN-102 treatment tend to remain event-free 24 months later, according to phase III ENVISION trial.
“UGN-102 is a reverse thermal hydrogel containing mitomycin (75 mg) recently approved by the US Food and Drug Administration for the primary nonsurgical treatment of adults with recurrent LG-IR-NMIBC,” the investigators said. [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle]
Two hundred forty patients with LG-IR-NMIBC participated in ENVISION and received at least a single dose of UGN-102. Most patients were White (98 percent), male (61 percent), and aged ≥65 years (68 percent). [J Urol 2026;216:194-205]
Of these, 191 (80 percent) achieved CR at 3 months. Among responders, the chances of remaining event-free at 2 years after CR was 72 percent (95 percent confidence interval, 64‒79).
Thirty-six of the 191 patients who achieved CR at 3 months developed low-grade disease recurrence. Dysuria was the most common treatment-emergent adverse event, occurring in ≥10 percent of the 240 enrolled patients.
“These data indicate that UGN-102 is a nonsurgical treatment that provides a durable CR for patients with recurrent LG-IR-NMIBC, addressing a critical unmet need in this population,” the investigators said.
Durable response
Treatment response was also durable, with 82-percent and 72-percent probability of being responsive at 12 and 24 months after CR, respectively. CR rates also remained high at 76 percent and 59 percent at 12 and 24 months, respectively.
Likewise, the estimated duration of response (DoR) in the ATLAS trial a year after CR was 80 percent following induction treatment with UGN-102 and 68 percent after primary transurethral resection of bladder tumour treatment (TURBT). [J Urol 2023;210:619-629]
In the OPTIMA II extended follow-up study, the median estimate of DoR was 24.2 months for patients achieving CR at 3 months, with a median follow-up of 35.8 months. Moreover, the median estimate of DoR was 42.1 months for the 17 patients who remained in CR at the end of the trial. [Clin Genitourin Cancer 2025;23:102392]
Notably, the adverse events reported in the ENVISION, ATLAS, and OPTIMA II studies were mostly mild to moderate in severity, localized to the urinary tract, and manageable, indicating an acceptable benefit-risk profile, according to the investigators. [J Urol 2025;213:205-216; J Urol 2022;207:61-69; J Urol 2023;210:619-629]
“In the current ENVISION trial, the response was also durable in exploratory subgroup analyses of patients with ≤1 and >1 prior TURBT to treat NMIBC, and single and multiple tumours at baseline,” they said. “Subgroup comparisons must be interpreted with caution due to the small sample size of some subgroups and the lack of statistical comparison.”
ENVISION trial
ENVISION is an ongoing phase III study in patients with biopsy-proven recurrent LG-IR-NMIBC, who received six once-weekly intravesical instillations of UGN-102. Participants then underwent cystoscopy, urine cytology testing, and for-cause biopsy to determine the presence of bladder cancer at 3 months.
The Kaplan-Meier method was used to estimate DoR (from CR at 3 months to disease recurrence, progression, or death from any cause) at 24 months.
“Treatment with UGN-102 avoids the need for general anaesthesia in this elderly patient population, who are likely to have a range of comorbidities; both general anaesthesia and comorbidities are associated with an elevated risk of postoperative complications,” the investigators said. [J Geriatr Oncol 2021;12:1022-1030; BJU Int 2022;130:463-469; Anesthesiology 2018;128:1140-1150]
“UGN-102 is administered in an outpatient clinical setting or by a trained practitioner in a patient's home,” they added. [Rev Urol 2025;24:e95-e106]