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CPX-351 in older patients with secondary or high-risk AML: Results from the phase II PETHEMA-LAMVYX trial
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Results from the phase II PETHEMA-LAMVYX trial (NCT04230239) of CPX-351 were published in Cancer by Rodríguez-Arbolí et al.1 The study validated the findings from the pivotal trial of CPX-351 and provided new insights, including impact of MRD, QoL, role of G‐CSF priming, and feasibility of CPX‐351 as a maintenance treatment in non-transplant setting in older patients with secondary or high-risk AML.1 A total of 59 patients, with a median age of 68 years, were included in the study. Post consolidation, 17% of patients underwent allo-HSCT and 15% entered maintenance treatment with CPX-351. |
| Key learnings |
| The primary endpoint of CR/CRi was achieved in 49% of patients, aligning with the results from the pivotal trial (CR/CRi, 48%) and suggesting that G-CSF priming had no significant impact on remission rates. MFC-MRD negativity was attained in 67% of patients. |
| The median ESF, DFS, and OS were 3.0 months, 10.6 months, and 7.4 months, while the 1-year EFS, DFS, and OS rates were 24%, 48%, and 37%, respectively. |
| Landmark analyses at Day 100 after diagnosis showed 1‐year OS and EFS of 70% each in patients receiving allo-HSCT and 89% and 44%, respectively, in those receiving maintenance treatment. |
| Baseline SI was associated with mortality at 4 weeks (SI >20, p = 0.007). There were no significant longitudinal changes in SI or EQ‐VAS scores after induction and consolidation phases, regardless of CR/CRi status. |
| The findings provide new insights on the safety and efficacy of CPX-351, including the role of allo-HSCT in older patients with secondary AML, which may help guide appropriate implementation of CPX-351 in clinical practice. However, the study was limited by a relatively small patient population, short follow-up time, and a non-randomized design. |
Abbreviations: AE, adverse event; allo-HSCT, allogeneic hematopoietic stem cell transplantation; AML, acute myeloid leukemia; CR, complete remission; CRi, CR with incomplete hematologic recovery; DFS, disease-free survival; EFS, event-free survival; G-CSF, granulocyte colony-stimulating factor; MFC, multiparameter flow cytometry; MRD, measurable residual disease; OS, overall survival; QoL, quality of life; SI, severity index.
- Rodríguez-Arbolí E, Rodríguez-Veiga R, Soria-Saldise E, et al. A phase 2, multicenter, clinical trial of CPX-351 in older patients with secondary or high-risk acute myeloid leukemia: PETHEMA-LAMVYX. Cancer. 2024. Online ahead of print. DOI: 1002/cncr.35618
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