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Molecular Profile FLT3 exon 14 ins
Therapy Azacitidine + Gilteritinib + Venetoclax
Indication/Tumor Type acute myeloid leukemia
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FLT3 exon 14 ins acute myeloid leukemia sensitive Azacitidine + Gilteritinib + Venetoclax Phase Ib/II Actionable In a Phase I/II trial, Venclexta (venetoclax), Vidaza (azacitidine), and Xospata (gilteritinib) treatment demonstrated safety in acute myeloid leukemia patients with FLT3-ITD or FLT3 D835 mutations and led to a combined complete remission (CR)/CR with incomplete hematologic recovery (CR/CRi) rate of 96% and a median relapse-free survival and median overall survival not reached in newly diagnosed patients (n=30), and a CR/CRi rate of 27% in relapsed/refractory patients (n=22) (PMID: 38277619; NCT04140487). 38277619
FLT3 exon 14 ins acute myeloid leukemia sensitive Azacitidine + Gilteritinib + Venetoclax Clinical Study Actionable In a retrospective analysis, real-world treatment with Xospata (gilteritinib), Venclexta (venetoclax), and Vidaza (azacitidine) resulted in a modified composite complete remission rate (mCRc) of 62.1% (18/29) and a 2-yr overall survival (OS) rate of 60.9% in acute myeloid leukemia patients with FLT3-ITD and/or TKD mutations, with an mCRc of 70% (7/10) and a 1-yr OS rate of 80% in patients without prior FLT3 TKI, and an mCRc of 57.9% (11/19) and a 1-yr OS rate of 58.8% with prior FLT3 TKI (PMID: 39180903). 39180903
PubMed Id Reference Title Details
(38277619) Azacitidine, Venetoclax, and Gilteritinib in Newly Diagnosed and Relapsed or Refractory FLT3-Mutated AML. Full reference...
(39180903) Triplet therapy with gilteritinib, venetoclax, and azacitidine for relapsed/refractory FLT3mut acute myeloid leukemia. Full reference...