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QuANTUM-First phase III exploratory analysis: Quizartinib maintenance in ND FLT3-ITD AML
An exploratory analysis of the randomized, double-blind, placebo-controlled, phase III QuANTUM-First trial (NCT02668653) evaluated quizartinib maintenance monotherapy vs placebo in adults with newly diagnosed (ND) FLT3-internal tandem duplication (FLT3-ITD) acute myeloid leukemia (AML) after induction and consolidation with the same assigned study treatment plus standard chemotherapy, with or without allogeneic hematopoietic stem cell transplantation (allo-HSCT). Among the 539 patients randomized, 208 received maintenance therapy (quizartinib group, n = 116; placebo group, n = 92). Overall survival (OS), event-free survival (EFS), and relapse-free survival (RFS) were prespecified outcomes; subgroup analyses by allo-HSCT and measurable residual disease (MRD) status were post hoc. These exploratory analyses were not powered to detect statistical significance. Results were published in Blood Advances by Levis et al.
Key data: At a median follow-up of 39.2 months overall and 31.7 months for the maintenance period, OS numerically favored quizartinib over placebo in patients who received maintenance therapy (hazard ratio [HR], 0.683; 95% confidence interval [CI], 0.395–1.183). Median EFS was similar between treatment groups (HR, 0.951; 95% CI, 0.658–1.375), while there was a trend toward improved RFS with quizartinib among evaluable patients (n = 166; HR, 0.738; 95% CI, 0.442–1.230). In patients without prior allo-HSCT (n = 89), quizartinib was associated with improved OS vs placebo (HR, 0.401; 95% CI, 0.192–0.838). OS favored quizartinib over placebo in both MRD-negative (n = 137; HR, 0.438; 95% CI, 0.193–0.991) and MRD-positive (n = 33; HR, 0.606; 95% CI, 0.225–1.633) patients; this benefit was particularly pronounced in non-transplanted, MRD-negative patients (HR, 0.194; 95% CI, 0.056–0.676).
Key learning: Quizartinib maintenance may deepen the benefit of first-line quizartinib-based therapy in ND non-transplanted patients with FLT3-ITD AML, particularly in MRD-negative patients, supporting its consideration in this setting.
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