Quizartinib regimen extends OS for certain patients with acute myeloid leukemia
The addition of quizartinib to chemotherapy extended OS for certain adults with newly diagnosed acute myeloid leukemia, according to topline data released by the agent’s manufacturer.
AML accounts for about one-third of leukemia diagnoses. Five-year survival is approximately 29%; however, prognosis is poorer for patients with FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD)-positive disease, who are at increased risk for relapse.
Quizartinib (Daiichi Sankyo) is a selective FLT3 inhibitor.
The randomized phase 3 QuANTUM-First trial included 539 adults (age range, 18-75 years) with newly diagnosed FLT3-ITD-positive AML.
Researchers randomly assigned patients 1:1 to quizartinib or placebo in combination with standard anthracycline- and cytarabine-based induction and consolidation regimens.
Eligible patients, including those who underwent allogeneic hematopoietic stem cell transplant, continued to receive single-agent quizartinib or placebo for up to 36 cycles.
OS served as the primary endpoint. Secondary endpoints included EFS, post-induction rates of complete remission and composite complete remission, and the percentage of patients who achieved complete remission or composite complete remission with FLT3-ITD minimal residual disease negativity.
The study achieved its primary endpoint, with results demonstrating prolonged survival among patients assigned quizartinib. The agent exhibited a manageable safety profile consistent with prior studies, according to researchers.
Complete data from the QuANTUM-First trial will be submitted for presentation at a medical conference and shared with regulatory authorities, according to a Daiichi Sankyo-issued press release.