Can TURBT be avoided? primary chemoablation with a reverse thermal gel containing mitomycin (UGN-102) in patients with low grade intermediate risk non-muscle invasive bladder cancer

INTRODUCTION: Low grade, intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC) is notable for a high rate of disease recurrence yet low risk of disease progression. Patients with LG IR-NMIBC therefore undergo repetitive transurethral resection of bladder tumors (TURBT), which can lead to increased morbidity and risks of repetitive anesthesia. We evaluated the efficacy and safety of non-surgical chemoablation in patients with LG IR-NMIBC using a reverse thermal hydrogel containing mitomycin (UGN-102) and report efficacy and interim durability. METHODS: Patients =18 years old with biopsy-proven LG NMIBC who met criteria for intermediate risk disease were enrolled in a prospective, single arm, open label Phase 2b trial. After confirmatory biopsy, visible lesions were left in situ. Patients received 6 weekly instillations of UGN-102 in an office setting. The chemoablative effect of UGN-102 was assessed at 3 months following treatment initiation, with complete response (CR) defined as a negative endoscopic examination, negative cytology, and when indicated, a negative for-cause biopsy. Patients achieving CR were followed quarterly for 12 months to evaluate safety, efficacy and durability. RESULTS: 63 patients (38 male, 25 female, 33-96 years old) were treated with UGN-102. The CR rate at 3 months follow-up was 65% (41/63). Of those with CR, 31/32 patients (97%) and 17/20 patients (85%) remained free of disease at 6 and 9 months follow-up, respectively. Follow up is ongoing. The most commonly reported adverse events to date were dysuria, hematuria, urinary frequency, fatigue, urgency, and urinary tract infection. CONCLUSIONS: These interim data demonstrate that nonsurgical primary chemoablation of LG IR-NMIBC using UGN-102 results in a considerable treatment response with encouraging durability. UGN-102 may provide an alternative to repetitive endoscopic surgery for patients with LG IR-NMIBC.