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Word count: 250/250Purpose: To evaluate long-term safety and durability of response to UGN-101, a mitomycincontaining reverse thermal gel, as primary chemoablative treatment for low-grade upper tract urothelial carcinoma (UTUC). Materials and Methods:In this open-label, single-arm, multi-center, phase 3 trial (NCT02793128), patients ≥18 years of age with primary or recurrent biopsy-proven low-grade UTUC received 6 once-weekly instillations of UGN-101 via retrograde catheter to the renal pelvis and calyces. Those with complete response (defined as negative ureteroscopic evaluation, negative cytology, and negative for-cause biopsy) 4-6 weeks after the last instillation were eligible for up to 11 monthly maintenance instillations and were followed for ≥12 months with quarterly evaluation of response durability. Durability of complete response was determined by ureteroscopic evaluation; duration of response was estimated by the Kaplan-Meier method.Treatment-emergent adverse events (TEAEs) were monitored. Results:Of 71 patients who initiated treatment, 41 (58%) had complete response to induction therapy and consented to long-term follow up; 23/41 patients (56%) remained in complete response after 12 months (95% CI: 40, 72), comprising 6/12 (50%) who did not receive any maintenance instillations and 17/29 (59%) who received ≥1 maintenance instillation. Kaplan-Meier analysis of durability was estimated as 82% (95% CI: 66, 91) at 12 months. Ureteric stenosis was the most frequently reported TEAE (31/71, 44%); an increasing number of instillations appeared to be associated with increased incidence of urinary TEAEs.

Background: There have been concerns regarding incidences of peritoneal recurrences and

Primary chemoablation of low-grade intermediate-risk non-muscle-invasive bladder cancer using UGN-102, a mitomycin-containing reverse thermal gel (OPTIMA II): a phase 2b, open-label, single-arm trial,

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