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CPX-351 for High-Risk AML: Phase III Post Hoc Analysis

By: Kelly M. Hennessey, PhD
Posted: Wednesday, May 5, 2021

Dual-drug CPX-351, a liposomal encapsulation of daunorubicin and cytarabine in a synergistic 1:5 molar ratio, has shown improved efficacy among patients with newly diagnosed high-risk or secondary acute myeloid leukemia (AML). When compared with the conventional 7+3 chemotherapy, CPX-351 significantly improved median overall survival in all therapy-related AML or AML with myelodysplasia-related changes, according to Jeffrey E. Lancet, MD, of the H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, and colleagues. Their results were published in Blood Advances.

“Results of the current analyses suggest the remissions achieved with CPX-351 treatment may permit more patients to proceed to hematopoietic cell transplantation versus 7+3 and lead to prolonged survival,” concluded the researchers.

In this open-label, controlled, multicenter, phase III trial, patients with newly diagnosed high-risk or secondary AML were randomly assigned to receive either induction therapy with CPX-351 or 7+3 chemotherapy. A total of 309 patients received CPX-351 (n = 153) or treatment with 7+3 (n = 156).

Of the total, 48% (n = 73) administered CPX-351 achieved a complete response or complete response with incomplete neutrophil or platelet recovery, and 33% (n = 52) achieved complete response and complete response with incomplete count recovery with 7+3 chemotherapy. Higher response rates were achieved in patients with therapy-related AML administered CPX-351. About 47% of patients achieved complete response and complete response with incomplete hematologic recovery compared with 36% of patients administered 7+3 chemotherapy.

For all patients who achieved complete response or complete response with incomplete hematologic recovery, the median duration of remission was 6.93 months with CPX-351 versus 6.11 months with 7+3 chemotherapy. Of the patients with complete responses, median relapse-free survival was significantly longer with CPX-351 than 7+3 chemotherapy (11.24 months vs. 8.82 months, respectively). The safety profile of CPX-351 was consistent with the known safety profile of 7+3 chemotherapy.

Disclosure: For full disclosures of the study authors, visit ashpublications.org.


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