Gilteritinib plus azacitidine in patients with newly diagnosed FLT3 mutation-positive acute myeloid leukemia who were ineligible for intensive chemotherapy: final results of the phase III LACEWING study

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In newly diagnosed FLT3-mutated acute myeloid leukemia patients ineligible for intensive chemotherapy, the addition of gilteritinib to azacitidine does not significantly improve overall survival compared to azacitidine alone, despite yielding higher overall response rates. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Eunice S. Wang; Pau Montesinos; Mark D. Minden; Hassan Sibai; Je-Hwan Lee; Michael Heuser; Tomoki Naoe; Wen‐Chien Chou; Kamel Laribi; Jordi Esteve; Jessica Altman; Violaine Havelange; Anne-Marie Watson; Monica Fumagalli; Elżbieta Patkowska; Jason E. Hill; Stanley C. Gill; Bhavik J. Pandya; Caroline Chen; Nahla Hasabou

doi:10.3324/haematol.2026.301112

Key Points

To evaluate the long-term efficacy and safety of gilteritinib plus azacitidine in patients with newly diagnosed FLT3-mutated acute myeloid leukemia who are ineligible for intensive chemotherapy.
Phase 3 open-label trial enrolling an initial safety cohort (n=15) and randomizing patients (n=168) to receive gilteritinib plus azacitidine, gilteritinib monotherapy, or azacitidine monotherapy.
Assessed final 6.5-year outcomes including overall survival, mutational subgroups, measurable residual disease, and pharmacokinetics.
Median overall survival reached 9.82 months with gilteritinib plus azacitidine versus 9.23 months with azacitidine alone (p=0.182) and 5.24 months with gilteritinib monotherapy.
Two-year overall survival rates were 18.8% for the combination arm, 12.9% for azacitidine, and 4.5% for gilteritinib.
Overall response rates were 70.2% for gilteritinib plus azacitidine versus 36.8% for azacitidine alone.

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Implication

Randomized trial reveals gilteritinib plus azacitidine fails to improve overall survival in FLT3-mutated acute myeloid leukemia, indicating the need for better therapies in chemo-ineligible patients.

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Wang et al. (2026) studied this question.

synapsesocial.com/papers/6a9bd4436b95aff0620ebbd8 https://doi.org/10.3324/haematol.2026.301112

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Gilteritinib plus azacitidine in patients with newly diagnosed FLT3 mutation-positive acute myeloid leukemia who were ineligible for intensive chemotherapy: final results of the phase III LACEWING study

Key Points

No abstract yet

Implication

Discussion

Cite This Study

Gilteritinib plus azacitidine in patients with newly diagnosed FLT3 mutation-positive acute myeloid leukemia who were ineligible for intensive chemotherapy: final results of the phase III LACEWING study

Key Points

No abstract yet

Implication

Discussion

Cite This Study

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