CPX-351 (vyxeos) in AML

Leuk Lymphoma. 2020 Feb;61(2):288-297. doi: 10.1080/10428194.2019.1660970. Epub 2019 Sep 24.

Abstract

For decades, the standard induction for patients with acute myeloid leukemia (AML) has been the combination of cytarabine with anthracycline (7 + 3 regimen). In August 2017 the US FDA approved CPX-351 (vyxeos), a liposomal formulation of cytarabine and daunorubicin at a fixed 5:1 molar ratio, for the treatment of adults with newly diagnosed AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML (t-AML). This is the first approved treatment specifically for patients with this subgroup of AML. The approval was based on findings from a multicenter, randomized, open-label, phase III study of CPX-351 Versus 7 + 3 in patients 60-75 years old with newly diagnosed AML-MRC or t-AML. In this study CPX-351 had a higher median OS than 7 + 3 (9.56 vs 5.95 months, HR 0.69; 95% CI: 0.52 to 0.90, p = 0.005). In this profile, we review preclinical and clinical data, and discuss limitations and future directions with CPX-351 use in AML.

Keywords: AML in elderly; AML-MRC; CPX-351; Vyxeos; sAML; t-AML.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Cytarabine / therapeutic use
  • Daunorubicin / therapeutic use
  • Humans
  • Leukemia, Myeloid, Acute* / diagnosis
  • Leukemia, Myeloid, Acute* / drug therapy
  • Middle Aged
  • Multicenter Studies as Topic
  • Myelodysplastic Syndromes* / drug therapy
  • Randomized Controlled Trials as Topic

Substances

  • CPX-351
  • Cytarabine
  • Daunorubicin