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Clinical Trial
. 2022 Oct 26;15(1):155.
doi: 10.1186/s13045-022-01361-w.

Efficacy and safety of CPX-351 versus 7 + 3 chemotherapy by European LeukemiaNet 2017 risk subgroups in older adults with newly diagnosed, high-risk/secondary AML: post hoc analysis of a randomized, phase 3 trial

Jorge E Cortes  1   2 , Tara L Lin  3 , Kobby Asubonteng  4 , Stefan Faderl  5 , Jeffrey E Lancet  6 , Thomas Prebet  7
Affiliations
Clinical Trial

Efficacy and safety of CPX-351 versus 7 + 3 chemotherapy by European LeukemiaNet 2017 risk subgroups in older adults with newly diagnosed, high-risk/secondary AML: post hoc analysis of a randomized, phase 3 trial

Jorge E Cortes et al. J Hematol Oncol. .

Abstract

CPX-351 (Europe: Vyxeos® liposomal; United States: Vyxeos®) is a dual-drug liposomal encapsulation of daunorubicin and cytarabine in a synergistic 1:5 molar ratio. In a phase 3 study in older adults with newly diagnosed, high-risk/secondary AML, CPX-351 improved the remission frequency, overall survival, and post-transplant survival versus 7 + 3. This post hoc analysis evaluated the final 5-year follow-up outcomes according to the European LeukemiaNet 2017 risk classification. CPX-351-treated patients had a higher remission frequency (adverse risk: 41% vs 26%; intermediate risk: 58% vs 39%) and longer median overall survival (adverse risk: 7.59 vs 5.52 months; intermediate risk: 11.86 vs 7.75 months) and post-transplant survival (adverse risk: 43.14 vs 7.08 months; intermediate risk: not reached vs 13.57 months) versus 7 + 3, with outcomes generally poorer among patients with adverse-risk AML. The safety profile of CPX-351 among patients with adverse-risk or intermediate-risk AML was consistent with that of the overall study population. Early mortality was lower, and hospitalization length of stay per patient-year was shorter with CPX-351 versus 7 + 3 within the adverse-risk and intermediate-risk subgroups. The favorable outcomes observed with CPX-351 in this post hoc analysis are consistent with results for the overall study population and further support the use of CPX-351 in these patients.ClinicalTrials.gov Identifier: NCT01696084.

Keywords: Acute myeloid leukemia; CPX-351; Chemotherapy; European LeukemiaNet 2017 risk subgroup; Post hoc.

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Conflict of interest statement

JEC has received consulting fees from Astellas Pharma, Daiichi Sankyo, Jazz Pharmaceuticals, Novartis, and Pfizer; and institutional research funding from Arog, Astellas Pharma, Daiichi Sankyo, Jazz Pharmaceuticals, Novartis, and Pfizer. TLL has received institutional research funding from AbbVie, Aptevo, Astellas Pharma, BioPath Holdings, Celgene, Celyad, Genentech/Roche, Gilead Sciences, Incyte, Jazz Pharmaceuticals, Mateon Therapeutics, Ono Pharmaceutical, Pfizer, Prescient Therapeutics, Seattle Genetics, Tolero Pharmaceuticals, and Trovagene. KA is a former employee of Jazz Pharmaceuticals. SF is a current employee of and holds stock or stock options in Jazz Pharmaceuticals. JEL has received consulting fees from Agios, Daiichi Sankyo, Jazz Pharmaceuticals, and Pfizer. TP has received institutional research funding and consulting fees from Jazz Pharmaceuticals.

Figures

Fig. 1
Fig. 1
Efficacy Outcomes by ELN 2017 Risk Subgroup. A CR, CRi, and CR + CRi; B Kaplan-Meier OS for patients with intermediate-risk AML; C Kaplan-Meier OS for patients with adverse-risk AML; D Kaplan-Meier OS landmarked from the date of HCT for patients with intermediate-risk AML; E Kaplan-Meier OS landmarked from the date of HCT for patients with adverse-risk AML. AML acute myeloid leukemia; CI confidence interval; CR complete remission; CRi complete remission with incomplete neutrophil or platelet recovery; ELN European LeukemiaNet; HCT hematopoietic cell transplantation; HR hazard ratio; KM Kaplan-Meier; NE not estimable; OR odds ratio; OS overall survival
See this image and copyright information in PMC

References

    1. Mayer LD, Tardi P, Louie AC. CPX-351: a nanoscale liposomal co-formulation of daunorubicin and cytarabine with unique biodistribution and tumor cell uptake properties. Int J Nanomed. 2019;14:3819–3830. doi: 10.2147/IJN.S139450. - DOI - PMC - PubMed
    1. European Medicines Agency. Vyxeos liposomal (previously known as Vyxeos). https://www.ema.europa.eu/en/medicines/human/EPAR/vyxeos-liposomal. Accessed June 15, 2022.
    1. Vyxeos® (daunorubicin and cytarabine) liposome for injection, for intravenous use [package insert]. Palo Alto, CA: Jazz Pharmaceuticals; 2021.
    1. Lancet JE, Uy GL, Cortes JE, et al. CPX-351 (cytarabine and daunorubicin) liposome for injection versus conventional cytarabine plus daunorubicin in older patients with newly diagnosed secondary acute myeloid leukemia. J Clin Oncol. 2018;36(26):2684–2692. doi: 10.1200/JCO.2017.77.6112. - DOI - PMC - PubMed
    1. Dohner H, Estey E, Grimwade D, et al. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017;129(4):424–447. doi: 10.1182/blood-2016-08-733196. - DOI - PMC - PubMed

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