Multicenter randomized phase 2 trial of quizartinib versus placebo for newly diagnosed FLT3-ITD-negative AML

The multicenter phase 2 QUIWI study in Spain randomized patients with newly diagnosed FLT3-ITD-negative AML to standard chemotherapy with the FLT3 inhibitor quizartinib or placebo, followed by quizartinib or placebo maintenance. The median event-free survival was 20.4 months in the quizartinib group and 9.9 months in the placebo group (p=0.046), while the median overall survival was not reached in the quizartinib group and 29.3 months in the placebo group (p=0.012). The most frequently reported adverse events (any grade) were fever, rash, diarrhea, and mucositis. The authors conclude that the addition of quizartinib to standard chemotherapy for newly diagnosed FLT3-ITD-negative AML was associated with signficant EFS and OS improvement.