Quizartinib Added to Standard Chemotherapy Improves Event-Free and Overall Survival in Newly Diagnosed FLT3‑ITD–Negative AML: Findings from the Phase II QUIWI Trial

Highlight

– The phase II randomized, double‑blind QUIWI trial (n=273) tested quizartinib 60 mg daily added to standard induction and consolidation chemotherapy followed by maintenance in adults (18–70 years) with newly diagnosed FLT3‑ITD–negative AML.

– Median event‑free survival (EFS) was 20.4 months with quizartinib vs 9.9 months with placebo (P = .046). Median overall survival (OS) was not reached with quizartinib vs 29.3 months with placebo (P = .012); 3‑year OS rates were 60.8% vs 45.7%.