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QuANTUM-First exploratory analysis: Quizartinib maintenance in patients with newly diagnosed FLT3-ITD AML
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Patients with ND FLT3-ITD AML achieved improved outcomes when quizartinib was added to induction, consolidation, and maintenance therapy in the phase III QuANTUM-First trial (NCT02668653).1 With a focus on MRD status, an exploratory analysis from QuANTUM-First assessed the impact of quizartinib vs placebo maintenance therapy in this population (n = 208; 116 received quizartinib, 92 received placebo). Results were presented by Levis during the 66th ASH Annual Meeting and Exposition.1 |
| Key learnings |
| Quizartinib vs placebo demonstrated higher OS (76.3% vs 67.9 at 48 months; HR, 0.683; 95% CI, 0.395–1.183) and RFS (67.1% vs 59.6% at 36 months; HR, 0.738; 95% CI, 0.442–1.230) and lower CIR rates (34.4% vs 25.9% at 36 months). |
| Among patients who received maintenance without prior allo-HSCT (n = 89), quizartinib vs placebo provided an OS benefit (median OS, NR vs 42.5 months), with a 60% reduction in the risk of death (HR, 0.401; 95% CI, 0.192–0.838). |
| Both MRD− and MRD+ patients experienced an OS benefit with quizartinib maintenance vs placebo. Median OS was NR in both arms in MRD− patients (HR, 0.438; 95% CI, 0.193–0.991) and 40.4 months vs in 21.9 months in MRD+ patients (HR, 0.606; 95% CI, 0.225–1.633). |
| In patients who received maintenance therapy without allo-HSCT, OS was higher with quizartinib vs placebo in MRD− patients (median OS, NR in both arms; HR 0.194; 95% CI, 0.056–0.676) and MRD+ patients (median OS, NR vs 42.5 months; HR, 0.411; 95% CI, 0.100–1.688). |
| This exploratory analysis shows that quizartinib maintenance improved survival outcomes in patients with ND FLT3-ITD AML and supports its use in induction, consolidation, and maintenance, regardless of MRD status. |
Abbreviations: allo-HSCT, allogeneic hematopoietic stem cell transplantation; AML, acute myeloid leukemia; ASH, American Society of Hematology; CI, confidence interval; CIR, cumulative incidence of relapse; FLT3-ITD, FMS-like tyrosine kinase 3 internal tandem duplication; HR, hazard ratio; MRD, measurable residual disease; ND, newly diagnosed; NR, not reached; OS, overall survival; RFS, relapse-free survival.
References
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