UGN-102 Chemoablation as TURBT Alternative for Patients With Recurrent Low-Grade Non-Muscle Invasive Bladder Cancer

According to results from the phase 3 ENVISION trial, chemoablation with UGN-102, a reverse thermal gel containing mitomycin, demonstrates clinical promise as an alternative to standard-of-care transurethral resection of the bladder tumor (TURBT) among patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer (NMIBC). 

“Due to the recurrent nature of [low-grade intermediate risk] NMIBC, patients often require multiple TURBTs, under general anesthesia, which are associated with well-documented morbidity and risks,” stated Sandip Prasad, MD, Morristown Medical Center, Morristown, New Jersey, and coauthors. “UGN-102…can be delivered using a minimally invasive procedure in an ambulatory setting via a urethral catheter.”

In this single-arm study, 228 untreated patients who experienced disease recurrence received a weekly intravesical instillation of UGN-102 (75 mg of mitomycin) for 6 weeks until disease recurrence, progression, or death. The primary end point was 3-month complete response rate. A key secondary end point was safety.

At analysis, the 3-month complete response rate was 79.6% and the estimated 12-month complete response rate was 82.3%. Within 15 months of treatment, 61% of patients maintained a complete response. Treatment-emergent adverse events occurred in 57.1% of patients. The most common treatment-emergent adverse events occurring in ≥5% of patients included dysuria (22%), hematuria (8.3%), urinary tract infection (7.1%), pollakiuria (6.7%), fatigue (5.4%), and urinary retention (5%). Grade ≥ 3 treatment-emergent adverse events occurred in 13.8% of patients. Two patients experienced serious treatment-emergent adverse events of urinary retention and urethral stenosis, however both were resolved. 

As Dr Prasad et al concluded, “UGN-102 is a minimally invasive, nonsurgical treatment that may represent an efficacious and well-tolerated alternative to TURBT for patients with recurrent [low-grade intermediate risk] NMIBC.” 

Source: 

Prasad SP, Shishkov D, Mihaylov NV, et al. Primary chemoablation of recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer with UGN-102: A single-arm, open-label, phase 3 trial (ENVISION). J Urol. Published online: October 24, 2024. doi: 10.1097/JU.0000000000004296