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Rebecca Olin, MD, MS


5-Year Results for CPX-351 in Older Adults With High-Risk AML

By: Sarah Campen, PharmD
Posted: Friday, January 15, 2021

CPX-351—a liposomal preparation of daunorubicin and cytarabine for injection—appears to improve survival in older adults with newly diagnosed high-risk or secondary acute myeloid leukemia (AML) compared with conventional 7+3 chemotherapy, according to the 5-year results of a phase III study presented during the 2020 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 635). “These data support prior evidence that CPX-351 has the ability to produce or contribute to long-term remission and survival in older patients with newly diagnosed high-risk or secondary AML,” stated Jeffrey E. Lancet, MD, of the H. Lee Moffitt Cancer Center & Research Institute, Tampa, and colleagues.

In this study, 309 patients were randomly assigned to receive either CPX-351 (n = 153) or standard 7+3, a combination of cytarabine and daunorubicin (n = 156). The estimated survival rates were higher for CPX-351 than for 7+3 at 3 years (21% vs. 9%) and at 5 years (18% vs. 8%), and the most common primary cause of death was progressive leukemia in both arms. When analyzed by age subgroup, improved median overall survival was also maintained in patients between the ages of 60 and 69 (9.59 vs. 6.87 months) and in those between the ages of 70 and 75 (8.87 vs. 5.62 months) with CPX-351 versus 7+3.

After 5 years of follow-up, improved overall survival with CPX-351 versus conventional 7+3 chemotherapy was maintained in the overall study population regardless of patient age, in those who underwent hematopoietic cell transplantation, and among patients who achieved complete remission or complete remission with incomplete platelet or neutrophil recovery, suggesting “potentially deeper responses may be achieved with CPX-351.”

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