Reference Detail

Ref Type

Journal Article

PMID

(39180903)

Authors

Fu Q, Wang Y, Liu H, Gao H, Sun W, Jiang Q, Jiang H, Liu K, Huang X, Tang F

Title

Triplet therapy with gilteritinib, venetoclax, and azacitidine for relapsed/refractory FLT3mut acute myeloid leukemia.

Journal	Vol	Issue	Date	Pages	Journal Short Title
Leukemia research	145		2024 Oct	107564	Leuk Res

URL

Abstract Text

The FMS-related tyrosine kinase 3 (FLT3) inhibitor gilteritinib is standard therapy for relapsed/refractory (R/R) FLT3-mutated (FLT3mut) acute myeloid leukemia (AML) but the overall survival (OS) is only approximately 20 % and few patients achieve deep and/ or durable response. We retrospectively analyzed 29 R/R FLT3mut AML patients treated on triplet regimens (gilteritinib+ venetoclax［VEN] +azacitidine［AZA]). Nineteen patients (65.5 %) had received prior FLT3 inhibitor therapy. The modified composite complete remission (mCRc) rate was 62.1 % (n = 18; CR, 4/29,13.8 %; CRi, 6/29, 20.7 %; MLFS, 8/29, 27.6 %). Among 18 patients achieved mCRc, FLT3-PCR negativity was 94.4 % (n=17), and flow-cytometry negativity was 77.7 % (n=14). The mCRc rate was 70 % (n=7) in 10 patients without prior FLT3 TKI exposure and 57.8 % (n=11) in 19 patients with prior FLT3 TKI exposure (P=0.52). At the end of the first cycle, the median time to ANC > 0.5× 109/L was 38 days and platelet > 50× 109/L was 31 days among responders, but 60-day mortality was 0 %. The estimated 2-year OS was 60.9 % for all R/R FLT3mut patients. The 1-year OS was 80 % and 58.8 % in patients without and with prior FLT3 TKI exposure, respectively (P=0.79). The estimated 2-year OS was 62 % in 19 (65.5 %) patients who received allo-HSCT after triplet therapy and 37 % in 10 patients who did not receive allo-HSCT (P=0.03). In conclusion, triplet therapy with gilteritinib, VEN, and AZA is effective and safe and an excellent frontline option for R/R FLT3mut AML.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

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	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 rate (OS) 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 of an 80% in patients without prior FLT3 TKI and an mCRc of 57.9% (11/19) and a 1-yr OS of 58.8% with prior FLT3 TKI (PMID: 39180903).	39180903