Apaziquone

This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in participants with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC), assessed according to the 2016 American Urology Association (AUA) Guidelines. Specifically, only participants with the following low-to intermediate-risk tumor characteristics were included in the study.
2016 American Urological Association Stratification for Non-Muscle Invasive Bladder Cancer:
Low Risk
Low grade solitary Ta ≤3 centimeters (cm)
Papillary urothelial neoplasm of low malignant potential (PUNLMP)
Intermediate Risk
Recurrence within 1 year, low-grade Ta
Solitary low-grade Ta >3 cm
Low-grade Ta, multifocal
High-grade Ta, ≤3 cm (solitary tumor)

This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder cancer (NMIBC), ≤3.5 centimeters (cm) in diameter, all of which must had been fully resected at TURBT.
In addition to Screening, participants underwent an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor Ta, G1-G2.
Following TURBT on Day 1, eligible participants were randomized to one of three treatment arms in a 1:1:1 ratio.
Arm 1 : One dose of Apaziquone. Arm 2 : Two Doses of Apaziquone. Arm 3 : Placebo. Primary endpoint was to evaluate the Time to Recurrence with either a one instillation of 4 mg apaziquone or two instillations of 4 milligram (mg) apaziquone relative to placebo instillation following TURBT in a participant with NMIBC who received TURBT.