Phase III trial of Vyxeos (cytarabine daunorubicin) shows improved response rate in acute myeloid leukemia- Celator Pharmaceuticals

Celator Pharmaceuticals has announced positive response rate results in acute myeloid leukemia (AML) patients with FLT3 (FMS-like tyrosine kinase-3) mutation, in the Company's Phase III trial of Vyxeos or CPX 351 (cytarabine daunorubicin) in patients with high-risk (secondary) acute myeloid leukemia. 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%).

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. In addition, preliminary data on NPM1 and CEBP? mutations were presented showing an improvement in response rate and overall survival in patients with these mutations. Final data for NPM1 and CEBP alpha mutations is expected to be presented at an upcoming medical conference. Data were presented at the European Hematology Association (EHA) 21st Annual Congress.

Comment:CPX-351 is a special formulation that uses a 5-to-1 ratio of cytarabine-daunorubicin packaged in tiny lyposomes to maintain the ratio as it is delivered intravenously to patients, offering an approach that could improve efficacy and help guard against side effects. Celator uses a platform technology, CombiPlex, to find the most "synergistic" formulations of drugs.