Recent data from the phase 3 ATLAS and ENVISION trials, which showed positive results for UGN-102 (mitomycin) as an intravesical treatment in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC), have been released by UroGen Pharma Ltd., a biotech company.
UGN-102 is a sustained-release, hydrogel-based formula that allows bladder tissue to be exposed to mitomycin longer, which enables the treatment of tumors without the use of surgery. The ATLAS and ENVISION trials both met their end points of disease-free survival and complete response, respectively, at 3 months of follow-up.
Patients in the ATLAS trial were randomized 1:1 to receive either UGN-102 or transurethral resection of bladder tumor (TURBT). A total of 282 patients were enrolled, and patients in the UGN-102 arm received UGN-102 in 6 weekly intravesical instillations. At a 3-month time point, UGN-102 was found to reduce the risk of recurrence, progression, or death by 55%. It showed a 64.8% complete response (CR) rate at 3 months compared with a 63.6% CR rate in patients who were treated with TURBT alone.
In the ENVISION trial, patients with low-grade, intermediate-risk NMIBC were given UGN-102 in 6 once-weekly intravesical instillations. The primary end point evaluated the CR rate at a 3-month assessment after the first instillation, where it achieved a CR rate of 79.2%.
UGN-102 was generally well-tolerated in both trials, with a side effect profile similar to profiles seen in previous clinical trials. Data analyzing the ENVISION trial’s secondary end point of duration of response are anticipated in 2024, along with the submission of a New Drug Application to the US Food and Drug Administration.