Additional Relevant Details
Data, independently validated, from AML patients with a FLT3 mutation demonstrated VYXEOS had a statistically significant improvement in induction response rate (CR+CRi of 68.2% versus 25.0%; p=0.007). A benefit in induction response rate was seen in both FLT3-ITD and FLT3-TKD patients.

An improvement in overall survival was also observed in FLT3 mutated patients with median overall survival of 10.25 months in the VYXEOS arm compared to 4.55 months in the 7+3 arm. The Hazard Ratio (HR) was 0.57 (p-value=0.093). In addition, preliminary data on NPM1 and CEBPα mutations were presented showing an improvement in response rate and overall survival in patients with these mutations. Final data for NPM1 and CEBPα mutations is expected to be presented at an upcoming medical conference.

Approximately 20-30% of AML patients harbor some form of FLT3 mutation. The significance of the mutation, in any given patient, varies according to the nature of the mutation and the context in which it occurs. The most common type of mutation is an internal tandem duplication (ITD) mutation localized to a membrane region of the receptor, while point mutations in the tyrosine kinase domain (TKD) are less common. AML patients with a FLT3 mutation are believed to have a poorer prognosis than the overall population diagnosed with AML.