Key clinical point: Addition of quizartinib to low-dose ara-C (LDAC) vs. LDAC alone improved survival and response in older patients with acute myeloid leukemia (AML) with an FMS-like tyrosine kinase 3-internal tandem duplication ( FLT3-ITD) mutation who were unfit for intensive chemotherapy (IC).
Major finding: Among patients with FLT3-ITD mutation, LDAC+quizartinib improved response in 38% of patients vs. 0% of patients receiving LDAC alone ( P = .02). The 2-year overall survival also improved significantly in patients receiving LDAC+quizartinib (hazard ratio 0.36; P = .024).
Study details: This study included 202 older patients with AML (de novo AML 63%; secondary AML 25%; high-risk myelodysplastic syndrome 11%) unsuitable for IC with (n = 27) or without FLT3-ITD mutation randomly assigned to receive LDAC+quizartinib or LDAC alone.
Disclosures: This study was supported by UK National Institute for Health Research, Blood Cancer UK, and Daiichi Sankyo. Some investigators reported being on advisory boards for, receiving research funding and honoraria from, or being an employee of various pharmaceutical companies, including Daiichi Sankyo.
Source: Dennis M et al. Blood Adv. 2021 Oct 1. doi: 10.1182/bloodadvances.2021005038.