Final safety and efficacy results from the CPX-351 early access program for older patients with high-risk or secondary acute myeloid leukemia. Academic Article uri icon

Overview

abstract

  • CPX-351, a dual-drug liposomal encapsulation of cytarabine and daunorubicin at a synergistic 5:1 molar drug ratio, achieved superior efficacy compared with conventional chemotherapy in older adults with newly diagnosed, high-risk/secondary acute myeloid leukemia (AML) in phase 2 and 3 studies. Prior to CPX-351 commercialization, an expanded access program (EAP) provided CPX-351 access for this population in the United States. In this phase 4, single-arm, open-label study (NCT02533115), 52 patients were treated with CPX-351 for 1-2 induction cycles and ≤4 consolidation cycles. The primary endpoint was safety. The most common serious adverse events were febrile neutropenia (19%), pneumonia (10%), and infection (8%). The 30- and 60-d mortality rates were 0% and 6%, respectively. Remission was achieved by 44% of patients; 90% of patients were alive at study completion. Overall, these results support outcomes from prior studies and the use of CPX-351 in older adults with newly diagnosed, high-risk/secondary AML.

authors

  • Roboz, Gail J
  • Larson, Melissa L
  • Rubenstein, S Eric
  • Solomon, Scott R
  • Schiller, Gary J
  • An, Qi
  • Chiarella, Michael
  • Louie, Arthur C
  • Lin, Tara L

publication date

  • February 26, 2020

Research

keywords

  • Antineoplastic Combined Chemotherapy Protocols
  • Leukemia, Myeloid, Acute

Identity

Scopus Document Identifier

  • 85084167756

Digital Object Identifier (DOI)

  • 10.1080/10428194.2020.1725503

PubMed ID

  • 32102577

Additional Document Info

volume

  • 61

issue

  • 5