US-based biopharmaceutical company Celator has announced positive Phase III results of VYXEOS (cytarabine: daunorubicin) Liposome for Injection in patients with high-risk (secondary) acute myeloid leukemia (AML).
Also known as CPX-351, VYXEOS is a nano-scale co-formulation of cytarabine and daunorubicin at a 5:1 molar ratio.
The ration of two drugs provides an anti-tumour activity while being encapsulated in a nano-scale liposome.
The randomised and controlled Phase III trial was performed in partnership with the Leukemia & Lymphoma Society (LLS) through its Therapy Acceleration Programme (TAP), which had supported the Phase II clinical trial of VYXEOS.
A total of 309 patients were enrolled in the Phase III trial from 39 sites in the US and Canada and divided into two age groups, between 60-69 years and 70-75 years.
The patients were also categorised in accordance to their afflictions with AML with myelodysplastic syndrome (MDS) with and without a prior treatment history with hypomethylating agent therapy, AML with a documented history of chronic myelomonocytic leukemia (CMMoL), and de novo AML with a karyotype characteristic of MDS.
They were administered with VYXEOS, as well as the traditional cytarabine and daunorubicin treatment regimen (7+3).
The company noted that the results showed an improvement in induction response rate in patients treated with VYXEOS and an overall improvement in response rate and survival of the patients.
Stanford University medical centre associate professor of medicine Bruno Medeiros said: "The improved response and survival observed in this exploratory analysis for VYXEOS over 7+3 in molecularly-defined AML subsets from the Phase III trial are promising, particularly for mutated FLT3 patients who typically have a poor prognosis.
"These clinical data corroborate previous ex vivo results suggesting increased sensitivity of FLT3 mutated AML blasts to VYXEOS and supports ongoing and prospective clinical studies in a broader range of AML cohorts."
Celator is planning to submit a new drug application (NDA) for VYXEOS with the US Food and Drug Administration (FDA) at the end of this year.