Phase III trial data shows improvement due to CPX 351 (cytarabine daunorubicin) in acute myeloid leukemia- Celator Pharma

Celator Pharmaceuticals has announced final induction response rate results (complete remission plus complete remission with incomplete hematologic recovery, or CR+CRi) in the Phase III study comparing CPX 351 (cytarabine daunorubicin) liposome injection to the standard of care regimen, referred to as 7+3 (conventional cytarabine and daunorubicin treatment), in patients with untreated high-risk (secondary) acute myeloid leukemia (AML).

The results showed that CPX 351 produced a relative improvement in induction response rate of 43.2% (47.7% for CPX 351 vs. 33.3% for the 7+3 regimen). Data on overall survival, the primary endpoint, are expected in the first quarter of 2016. However, induction response rate is a key secondary endpoint in the study and has been an important surrogate of overall survival and clinical benefit in this patient population. These data validate the induction response rates observed in the Phase II study, which was associated with a marked improvement in overall survival.

Comment: This is the third randomized study in which CPX 351 outperformed the control arm of cytarabine plus an anthracycline in overall response rate, according to Jeffrey Lancet, M.D., Senior Member and Chief of the Leukemia/Myelodysplasia Program at Moffitt Cancer Center and lead investigator on the Phase III study.