Midostaurin Plus CLAG-M Yields Comparable Results to Midostaurin Plus 7+3 Therapy, High Remission Rates Among Patients With FLT3-Mutated AML

For patients with acute myeloid leukemia (AML) who have an FLT3 mutation, treatment with midostaurin combined with cladribine, high-dose cytarabine, GCSF, and mitoxantrone (CLAG-M), is as safe and effective as with standard 7+3 therapy, according to a retrospective review published in Annals of Pharmacotherapy.

Cytarabine and anthracycline (7 + 3), the standard therapy for AML, with additional midostaurin has demonstrated improved patient outcomes, including overall survival (OS) and event-free survival. Other lines of therapy such as CLAG-M are used for the treatment of newly diagnosed or relapsed/refractory (R/R) AML, with midostaurin added for patients with a FLT3 mutation. However, research is limited on the effects of additional midostaurin combined with cytarabine therapies.

Researchers conducted a retrospective analysis of patients with FLT3-mutated AML receiving induction or reinduction therapy to compare the safety and efficacy profiles of midostaurin combined with CLAG-M or with standard therapy. The primary outcome was adverse event incidence, and secondary outcomes were disease response and mortality at 28 days.

Among 80 patients treated with FLT3-mutated AML, patients were treated either with a midostaurin plus CLAG-M regimen (n = 36) or with a midostaurin plus standard therapy (n = 44).

Rates of adverse events were not different between both therapy lines combined with midostaurin, patients receiving standard therapy had slightly more reports of diarrhea and bleeding. Complete remission rates were not significantly different between patients treated with combination midostaurin plus CLAG-M therapy (86%) and patients treated with midostaurin plus standard therapy (70%; P = . 11). 

“The toxicity profile of CLAG-M combined with midostaurin is comparable with the combination of 7+3 [standard therapy] with midostaurin and induces high remissions rates in adults with FLT3-mutated AML,” the researchers concluded.

Source:

Chen A, Baek G, Russell K, et al. Evaluation of the toxicity and outcomes of the combination of midostaurin and CLAG-M in patients With FLT3-mutated acute myeloid leukemia (AML): a multicenter retrospective analysis. Annals of Pharmacotherapy. Published online January 12, 2025. 10.1177/10600280241305608