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The following is a summary of “Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION),” published in the February 2025 issue of Journal of Urology by Prasad et al. 

Researchers conducted a retrospective study on UGN-102 chemoablation for recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer. 

They conducted a multinational, single-arm, phase 3 study in patients with biopsy-proven recurrence of untreated low-grade intermediate-risk nonmuscle-invasive bladder cancer. Patients received 6 weekly intravesical instillations of UGN-102 (mitomycin) in an outpatient setting and were evaluated at 3 months. Those achieving complete response (CR) were surveilled until recurrence, progression, or death. Patients who remained disease-free were followed up to 5 years. 

The results showed that 228 of 240 patients (95%) received all 6 doses. 191 patients (80%; 95% CI, 73.9-84.5) achieved CR at 3 months, with an 82% (95% CI, 75.9-87.1) probability of response at 12 months. Median duration of response was not estimable over a median 13.9-month follow-up. The most common adverse events (≥5%) were dysuria, hematuria, UTI, pollakiuria, fatigue, and urinary retention, all mild/moderate and resolved. Serious adverse events occurred in 29 patients (12.1%), with 2 treatment-related (urinary retention/urethral stenosis), both resolving. 

Investigators concluded that primary chemoablation with UGN-102 resulted in an 80% CR rate and an 82% likelihood of remaining disease-free at 1 year. The benefit-risk profile supported UGN-102 as a nonsurgical alternative for transurethral resection of bladder tumors. 

Source: auajournals.org/doi/10.1097/JU.0000000000004296