For patients with low-grade, intermediate-risk non-muscle-invasive bladder cancer (NMIBC), UGN-102 generated robust and durable responses in an analysis of the phase 3 ENVISION and ATLAS studies, according to findings that were presented at the 2025 Genitourinary Cancers Symposium.
Glossary:
Complete response: disappearance of all detectable disease following treatment.
Transurethral resection of bladder tumor (TURBT): surgical procedure to remove bladder tumors via the urethra.
Kaplan-Meier estimate: statistical method to estimate survival probabilities over time.
Hematuria: presence of blood in urine.
Micturition urgency: sudden, strong need to urinate.
Pollakiuria: abnormally frequent urination.
Urethral stenosis: narrowing of the urethra, leading to urinary obstruction.
Nocturia: frequent urination at night.
Malaise: general feeling of discomfort or unease.
Disease-free survival (DFS): time from treatment to disease recurrence or death.
Duration of response (DOR): length of time a tumor responds to treatment without progression.
Mitomycin-containing reverse thermal hydrogel: temperature-sensitive gel that delivers mitomycin intravesically for bladder cancer treatment.
Intravesical treatment with UGN-102: non-surgical therapy using a mitomycin-based reverse thermal gel for low-grade bladder cancer.
In the single-arm ENVISION trial, 79.6% of patients with recurrent disease who received UGN-102 (240 patients) achieved a complete response (CR) at three months, and the estimated 12-month CR rate was 82.3%.
In the randomized ATLAS trial, 64.8% of patients with newly diagnosed or recurrent disease who received UGN-102 with or without subsequent transurethral resection of bladder tumor (TURBT; 142 patients) achieved a CR at three months versus 63.6% of those who underwent TURBT (140 patients). The Kaplan-Meier estimated 12-month CR rates in these respective arms were 79.7% and 67.7%.
“These results demonstrate that treatment with UGN-102 results in a high and clinically meaningful durable CR rate in patients with newly diagnosed or recurrent low-grade, intermediate-risk NMIBC,” lead study author Dr. Sandip M. Prasad, of Morristown Medical Center, Atlantic Medical Group, in New Jersey and coauthors wrote in a poster presentation of the data.
Safety Data
The most common side effect observed with UGN-102 across both trials was dysuria, which was reported in 22.5% and 30.4% of patients who received the UGN-102 in ENVISION and ATLAS, respectively.
Previously reported safety findings from ENVISION showed that additional treatment-emergent side effects with UGN-102 included hematuria (8.3%), urinary tract infection (7.1%), pollakiuria (6.7%), fatigue (5.4%), urinary retention (5%), urethral stenosis (4.6%), COVID-19 (3.8%), constipation (3.8%), nausea (3.8%) and micturition urgency (3.3%).
Previously reported safety findings from ATLAS demonstrated that additional treatment-emergent side effects in the UGN-102 and TURBT arms, respectively, included micturition urgency (18%; 7.6%), nocturia (18%; 6.8%), pollakiuria (16%; 6.1%), flatulence (9.4%; 3%), COVID-19 (8.0%; 6.1%), erectile dysfunction (6.5%; 3%), hematuria (6.5%; 4.5%) and malaise (5.8%; 1.5%).
“UGN-102 may represent an efficacious and well-tolerated treatment option for patients with low-grade, intermediate-risk NMIBC,” the authors wrote in the poster.
Additional Updated Efficacy Findings
Among the patients in the ENVISION and ATLAS trials, respectively, 68% and 60% were at least 65 years of age; 98% and 99% were White; and 61% and 70% were male.
The median duration of response (DOR) was not estimable in any of the 3 trial arms because of low recurrence rates. In ENVISION, at a median follow up for DOR of 13.86 months, 17.3% of complete responders (191 patients) had disease recurrence, including low-grade disease (14.1%) and high-grade disease (2.1%). Two patients had died.
In the UGN-102 arm, at a median follow-up for DOR of 12.45 months, 19.6% of complete responders (92 patients) had disease recurrence, including low-grade disease (16.3%) and high-grade disease (3.3%). No patients in this arm had died. In the TURBT arm, at a median follow-up for DOR of 12.16 months, 27% of complete responders (89 patients) had disease recurrence, including low-grade disease (19.1%) and high-grade disease (6.7%). One patient in this arm had died.
ENVISION and ATLAS Background and Design
TURBT is the current standard of care (SOC) for patients with low-grade, intermediate-risk NMIBC; however, the study authors noted that this treatment method provides inadequate disease control and that patients often need to undergo multiple TURBTs under general anesthesia, which has associated complications, particularly for elderly patients. To address this need, the ENVISION and ATLAS trials studied the efficacy of intravesical treatment with UGN-102, a mitomycin-containing reverse thermal hydrogel, in patients with low-grade, intermediate-risk NMIBC.
