Phase III QuANTUM-Wild trial design: Quizartinib + IC in ND FLT3-ITD-negative AML

The ongoing double-blind, randomized, phase III QuANTUM-Wild trial (NCT06578247) is evaluating the safety and efficacy of quizartinib in combination with standard induction and consolidation chemotherapy, followed by maintenance monotherapy, for the treatment of newly diagnosed (ND) FLT3-internal tandem duplication (FLT3-ITD)-negative acute myeloid leukemia (AML). The rationale and trial design, informed by the phase II QUIWI trial (NCT04107727) in which quizartinib improved overall survival (OS) vs placebo in patients with ND FLT3-ITD-negative AML, were published in Future Oncology by Montesinos et al.

Key data: Approximately 700 patients aged 18–70 years will be randomized to receive either: quizartinib + standard induction and consolidation chemotherapy, followed by up to 36 cycles of quizartinib maintenance monotherapy (Arm A, n ≈ 280); placebo + chemotherapy followed by placebo maintenance (Arm B, n ≈ 280); or quizartinib + chemotherapy followed by placebo maintenance (Arm C, n ≈ 140). The primary endpoint is OS in Arm A vs Arm B. Secondary endpoints include event-free survival (EFS), complete response (CR) rate, measurable residual disease (MRD) negativity, and safety.

Key learning: The QuANTUM-Wild trial will assess the potential use of quizartinib, regardless of FLT3 mutational status, in patients with ND AML who are eligible for intensive chemotherapy; the three-arm design also allows prospective assessment of the contribution of quizartinib maintenance monotherapy in FLT3-ITD-negative AML.