A recent Phase 3 trial, named ENVISION, has demonstrated promising results for UGN-102 as a primary chemoablation treatment for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC). The study, a multinational, single-arm trial, revealed a 79.6% complete response (CR) rate at 3 months following six weekly intravesical instillations of UGN-102. This offers a potential non-surgical alternative to transurethral resection of bladder tumors (TURBT) for this patient population.
The ENVISION trial enrolled 240 patients with biopsy-proven recurrence of untreated low-grade intermediate-risk NMIBC. Of these, 228 patients (95%) received all six planned doses of UGN-102. Complete response was defined as a negative cystoscopic examination, cytology, and for-cause biopsy. The study's primary endpoint was the complete response rate at 3 months.
Sustained Response and Safety Profile
Beyond the initial complete response rate, the trial also assessed the durability of the response. Results indicated an 82.3% (95% CI: 75.9, 87.1) probability of maintaining the response 12 months after achieving CR. The median duration of response was not estimable over a median follow-up period of 13.9 months, suggesting a potentially long-lasting effect of the treatment.
The safety profile of UGN-102 was also favorable. The most common adverse events (≥5.0% of patients) included dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention. These adverse events were generally mild to moderate in severity and resolved without significant intervention. Serious adverse events were observed in 29 out of 240 patients (12.1%), with only two events (urinary retention and urethral stenosis) considered treatment-related, both of which resolved.
Clinical Implications
These findings suggest that UGN-102 could represent a significant advancement in the treatment paradigm for recurrent low-grade intermediate-risk NMIBC. Currently, TURBT is the standard initial treatment, but it carries risks and can lead to recurrence. UGN-102 offers a non-surgical option that could reduce the need for repeated surgical interventions.
According to Dr. Sandip M Prasad, from Morristown Medical Center/Atlantic Health System and Garden State Urology, “Primary chemoablation with UGN-102 in patients with recurrent low-grade-intermediate-risk-nonmuscle-invasive bladder cancer resulted in a 79.6% CR rate. Patients achieving a CR had an 82.3% likelihood of remaining disease-free 1 year later. The benefit-risk profile was favorable, supporting UGN-102 as a non-surgical alternative for transurethral resection of bladder tumors in this patient population.”
Study Limitations
The study authors noted one limitation: the lack of tumor sizing after the diagnostic biopsy. Further research may explore the correlation between tumor size and treatment response to optimize patient selection for UGN-102 therapy. The trial is ongoing (ClinicalTrials.gov Identifier: NCT05243550), and long-term follow-up data will provide further insights into the durability and overall efficacy of UGN-102 in this patient population.
