A randomized phase 2 study combining midostaurin, low-dose cytarabine and venetoclax in newly diagnosed AML ≥60 years.

Adding midostaurin to low-dose cytarabine and venetoclax improves overall survival in older patients with FLT3-ITD AML, with a median of 24.2 months versus 8.8 months.

• Why it matters: FLT3-ITD mutations are a key resistance mechanism in AML, and current therapies have limited success, especially in unfit older patients. Improving treatment options for this subgroup is crucial to enhance survival outcomes.
• What they did: The INTERVENE study randomized 120 newly diagnosed AML patients aged 60 or older to receive either low-dose cytarabine, venetoclax, and midostaurin (LVM) or without midostaurin (LV), after establishing tolerability in a run-in phase.
• The result: Midostaurin addition increased composite complete remission in FLT3-ITD patients to 82% from 57%, improved FLT3-ITD clearance to 65% from 0%, and extended median overall survival, suggesting a potential role in this patient population.