(UroToday.com) The American Urological Association (AUA) 2025 Annual Meeting, held in Las Vegas, NV, was host to a non-invasive bladder cancer podium session. Dr. Sandip Prasad presented the interim results of ENVISION, an ongoing single arm, open label, phase III trial evaluating UGN-102 for the treatment of recurrent, low-grade, intermediate-risk (LG-IR) non-muscle invasive bladder cancer (NMIBC).
LG-IR-NMIBC is a persistent cancer that frequently recurs despite treatment with the current standard of care, TURBT. UGN-102 is a reverse thermal gel containing mitomycin developed as a non-surgical treatment option for LG-IR-NMIBC.
ENVISION is an ongoing, multinational, single-arm, phase III trial in patients with a biopsy-proven recurrence of untreated LG-IR NMIBC.1 Eligible patients received 6 weekly intravesical instillations of UGN-102 and were evaluated at three months. Patients achieving complete response (CR; negative cystoscopic examination, cytology, and for-cause biopsy) underwent regular surveillance until recurrence, progression, or death. Patients who remained disease-free were planned for long-term follow-up (up to 5 years). Conversely, patients without a complete response at 3 months were offered standard of care therapy. The primary endpoint was 3-months complete response.
Of 240 patients enrolled, 228 (95%) received all 6 planned doses. The 3-months complete response rate was 80% (95% CI: 74–84.5%), with an 81% (95% CI: 74–86%) probability of a maintained response at 12 months. The median duration of response was not estimable over a median 13.9-month follow-up period.
The most common adverse events (≥5% of patients) were dysuria, hematuria, UTI, pollakiuria, fatigue, and urinary retention; generally mild/moderate and resolved/resolving. Serious adverse events were observed in 29/240 (12.1%); 2 were treatment related (urinary retention/urethral stenosis), and both resolved.
Dr. Prasad concluded as follows:
- Results from ENVISION demonstrate that treatment with UGN-102 results in a robust and clinically meaningful CR rate (80%) in patients with recurrent LG-IR NMIBC
- Trial participants who achieved an initial CR had a high probability (81%) of remaining disease-free 18 months later
- UGN-102 may represent a well-tolerated, valuable alternative to TURBT for patients with LG-IR-NMIBC
Presented by: Sandip Prasad, MD, MPhil, Vice Chair of Urology and Surgical Director of GU Oncology, Atlantic Health System, Morristown Medical Center, Morristown, NJ; Clinical Associate Professor, Rutgers-New Jersey Medical School, Newark, NJ; Thomas Jefferson University, Philadelphia, PA
Written by: Rashid K. Sayyid, MD, MSc – Robotic Urologic Oncology Fellow at The University of Southern California, @rksayyid on Twitter during the 2025 American Urological Association (AUA) annual meeting held in Las Vegas, NV, Saturday, April 26 - Tuesday, April 29, 2025
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