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Impact of baseline gene mutations on quizartinib survival benefits in patients with FLT3-ITD+ AML: Post hoc analysis of the QuANTUM-First trial
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During the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, Levis presented results from an exploratory post hoc analysis of the phase III QuANTUM-First trial (NCT02668653) evaluating the impact of co-mutations on survival benefits with quizartinib in patients with FLT3-ITD+ ND AML.1 |
| Key learnings |
| Among 518 evaluable patients with FLT3-ITD+ AML, mutations were detected in 96.5%, with NPM1 (54%) and DNMT3A (43%) being the most common. NPM1 and DNMT3A were co-mutated in 32% of patients. |
| Quizartinib demonstrated substantial survival benefits across most mutational subgroups, including NPM1 (mOS: NE vs 15.1 months; mRFS: 48.6 vs 12.6 months) and DNMT3A (mOS: 40.4 vs 9.6 months; mRFS: 48.6 vs 8.5 months). Survival benefits with quizartinib vs placebo were most pronounced in patients harboring triple mutations (FLT3-ITD + NPM1 + DNMT3A), with mOS of NE vs 9.6 months and mRFS of 48.6 vs 7.1 months. |
| CRc rates were similar with quizartinib vs placebo in patients with NPM1 (85% vs 82%) and DNMT3A (77% vs 69%) mutations, indicating absence of primary resistance to quizartinib due to baseline mutations. |
| In the QuANTUM-First trial, quizartinib consistently improved survival in patients with ND FLT3-ITD+ AML vs placebo, irrespective of co-occurring baseline mutations. |
Abbreviations: AML, acute myeloid leukemia; CRc, composite CR (complete remission [CR] or CR with incomplete blood count recovery [CRi]); ITD, internal tandem duplications; m, median; ND, newly diagnosed; NE, not evaluable; OS, overall survival; RFS, relapse-free survival.
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