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.
In both studies, patients in the UGN-102 arms received UGN-102 via a urinary catheter at 75 milligrams once weekly for six months. In ENVISION, patients with recurrent disease received UGN-102, and those without a CR at three months subsequently received SOC treatment and entered the follow-up period. In ATLAS, patients with newly diagnosed or recurrent disease were randomly assigned to receive UGN-102 or TURBT. Those without a CR with residual low-grade disease subsequently received TURBT and entered the follow-up period. All patients in both trials were examined for bladder cancer recurrence using cystoscopy, urine cytology and for-cause biopsy at three months and at regular intervals thereafter.
In ENVISION, the primary end point was CR at three months. In ATLAS, the primary end point was disease-free survival (DFS). Secondary end points in both trials included DOR and safety.
Notably, previously reported findings from ATLAS showed that UGN-102 with or without TURBT generated similar estimated DFS outcomes for patients with newly diagnosed versus recurrent disease. The estimated 15-month DFS rate with UGN-102 was 77.4% in patients with newly diagnosed disease versus 63.2% in those with recurrent disease.
References:
- “Treatment of Low-Grade Intermediate-Risk Non-Muscle-Invasive Bladder Cancer With UGN-102: Results of the Phase 3 ATLAS and ENVISION Studies” by Dr. Prasad S, et al., J Clin Oncol.
- “Response to Primary Chemoablation With UGN-102 in Patients With New or Recurrent LG IR NMIBC: Post-Hoc Analysis of the ATLAS Trial” by Dr. Prasad SM, et al., J Urol.
- “Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION)” by Dr. Prasad SM, et al., J Urol.
- “Treatment of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102 ± Transurethral Resection of Bladder Tumor Compared to Transurethral Resection of Bladder Tumor Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS)” by Dr. Prasad SM, et al., J Urol.
For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.
