Treatment of low-grade intermediate-risk non-muscle invasive bladder cancer with UGN-102: Results of the phase 3 ATLAS and ENVISION studies.
Year: 2025
Type: conference-abstract
Abstract: e16595 Background: In the ATLAS and ENVISION phase 3 studies (NCT04688931/NCT05243550) patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) were treated with UGN-102, a reverse thermal hydrogel containing mitomycin. Primary efficacy and safety results were previously reported for the individual studies; here we report additional data. Methods: In the randomized controlled ATLAS study, patients with newly diagnosed or recurrent LG-IR-NMIBC were randomized to 6 weekly intravesical instillations of UGN-102 (n=142) or transurethral resection of bladder tumor (TURBT) (n=140). In the single-arm ENVISION study, patients with recurrent LG-IR-NMIBC received 6 weekly intravesical instillations of UGN-102 (n=240). In both trials, patients were examined for recurrence of bladder cancer using cystoscopy, urine cytology testing, and for-cause biopsy at 3 months, and in those with a complete response (CR), at regular intervals thereafter. Duration of response (DoR) was calculated using the Kaplan–Meier method. Results: In ATLAS and ENVISION, most patients were age ≥65 years (60%, 68%), white (99%, 98%), and male (70%, 61%). In ATLAS, 92 patients (64.8%) in the UGN-102 arm and 89 patients (63.6%) in the TURBT arm had a CR at 3 months. Among patients achieving a CR at 3 months in ATLAS, the probability of remaining event (recurrence, progression, or death) free 12 months later was 79.7% in the UGN-102 arm vs 67.7% in the TURBT arm; the most common event was LG disease recurrence (Table). In ENVISION, 79.6% had a CR at 3 months, and the probability of remaining event free 12 months later was 82.3%; the most common event was recurrence of LG disease (Table). Median DoR was not estimable in any arm due to low event rates, with a between arms hazard ratio in ATLAS of 0.46 (95% confidence interval [CI] 0.24, 0.86) favoring the UGN-102 arm. The most common adverse event with UGN-102 in both studies was dysuria, occurring in 30.4% in ATLAS and 22.5% in ENVISION. Conclusions: In both studies, CR rate in patients initially treated with UGN-102 was robust, with the majority of patients remaining event free at 12 months follow-up. 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 LG-IR-NMIBC. UGN-102 may represent a valuable nonsurgical treatment option for these patients. Clinical trial information: NCT04688931 / NCT05243550 . ATLAS ENVISION UGN-102 TURBT UGN-102 CR at 3 months 92/142 (64.8%) 89/140 (63.6%) 191/240 (79.6%) CR rate (95% CI) 64.8 (56.3, 72.6) 63.6 (55.0, 71.5) 79.6 (73.9, 84.5) Median follow-up time for DoR, months (95% CI) 12.45 (12.02, 14.13) 12.16 (11.89, 12.75) 13.86 (12.19, 14.52) Event occurrence 18/92 (19.6%) 24/89 (27.0%) 33/191 (17.3%) LG disease 15/92 (16.3%) 17/89 (19.1%) 27/191 (14.1%) HG disease 3/92 (3.3%) 6/89 (6.7%) 4/191 (2.1%) Death 0 1/89 (1.1%) 2/191 (1.0%) HG, high grade.
Source: Journal of Clinical Oncology
Authors: Sandip M. Prasad, Marc Bjurlin, Dimitar Shishkov, Nikola V. Mihaylov, Alexandre Khuskivadze, Pencho Genov, Vasyl Terzi, Max Kates, Willliam C. Huang, Michael J. Louie, Sunil Raju, Brent Burger, Andrew Meads, Brian Hu, The ENVISION and ATLAS Study Groups
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funder: UroGen Pharma
OpenAlex ID: W4410816741