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news.Celator Pharmaceuticals announced that the Phase 3 clinical trial of VYXEOS (cytarabine:daunorubicin) Liposome for Injection (also known as CPX-351) in patients with untreated high-risk (secondary) acute myeloid leukemia (AML) has reached its pre-specified number of events required for the analysis of overall survival.
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The randomized, controlled, Phase 3 study (Protocol NCT01696084), conducted at 39 centers in the United States and Canada, compared VYXEOS to the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3) as first-line therapy.
Phase 3 Study with VYXEOS
The study enrolled 309 patients between the ages of 60 and 75 who had pathologically confirmed diagnosis of high-risk AML by WHO criteria including: therapy-related AML, AML with a history of myelodysplasia (MDS), AML with a history of chronic myelomonocytic leukemia (CMMoL), and de novo AML with karyotypic abnormalities characteristic of MDS.
Patients were randomized 1:1 to receive either VYXEOS (100u/m2; days 1, 3, and 5 by 90-minute infusion) or 7+3 (cytarabine 100mg/m2/day by continuous infusion for 7 days and daunorubicin 60mg/m2 on days 1, 2, and 3).
The study was conducted in partnership with The Leukemia & Lymphoma Society (LLS) through its Therapy Acceleration Program (TAP), which has supported the clinical development of VYXEOS beginning in Phase 2.