Table 2 Comparison of available therapies for unfit patients with newly-diagnosed FLT3 mutated acute myeloid leukemia.

From: Newly diagnosed acute myeloid leukemia in unfit patients: 2026 treatment algorithms

 

Sorafenib + Azacitidine

Quizartinib + Azacitidine or Low-dose cytarabine

Quizartinib + Decitabine-Ven

Gilteritinib + Azacitidine vs. placebo + azacitidine

Gilteritinib + Azacitidine-Ven

Venetoclax (Ven) + Azacitidine vs. placebo + Azacitidine

N

27

34

26

74 vs. 49

30

42 vs. 22

FLT3 mutation

FLT3-ITD

FLT3-ITD

FLT3-ITD

FLT3-ITD + TKD

FLT3-ITD + TKD

FLT3-ITD + TKD

Median age

74 years

72 years

70 years

78 vs. 76 years

71 years

75 vs. 75 years

CR/CRi (CR)

71% (26%)

87% (53%) (Quiz-Aza)

74% (5%) (Quiz-LDAC)

92% (69%)

58% vs. 27% (16% vs. 14%)

96% (90%)

67% (38%) vs. 36%

63% (30%) vs. 46% (15%)(FLT3-ITD)

77% (54%) vs. 30% (20%) (FLT3-TKD)

Median

Overall survival

8.3 months

19.2 months (Quiz-Aza)

8.5 months (Quiz-LDAC)

Not reached

9.8 vs. 8.9 months

Not reached

9.9 months (FLT3-ITD)

19.2 months (FLT3-TKD)

FLT3i adverse events

Grade 3 infections (26%)

Diarrhea (22%)

↑ bilirubin (22%)

Nausea (19%)

Grade 3 QTc prolongation (6%)

Pneumonia (38%)

Neutropenic fever (57%)

No grade 3

Qtc prolongation

Fever (48%)

Diarrhea (38%)

≥Grade 3 infection (53%)

Febrile neutropenia (33%)

Renal injury (7%)

≥Grade 3

Febrile neutropenia (38%)

↓ platelets (38%)

Reference

Ohanian et al., AJH 2018

Swaminathan et al.,

Haematologica 2021

Yilmaz et al.,

HemaSphere 2025

Wang et al., Blood 2020

Short et al., JCO 2024

Konopleva et al.,

Clin Cancer Res 2022