All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.
The AML Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy
Introducing
Now you can personalise
your AML Hub experience!
Bookmark content to read later
Select your specific areas of interest
View content recommended for you
Find out moreThe AML Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the AML Hub cannot guarantee the accuracy of translated content. The AML Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The AML Hub is an independent medical education platform, sponsored by Daiichi Sankyo, Jazz Pharmaceuticals, Johnson & Johnson, Kura Oncology, Roche, Syndax and Thermo Fisher, and has been supported through a grant from Bristol Myers Squibb. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
CPX-351 in older patients with secondary or high-risk AML: Results from the phase II PETHEMA-LAMVYX trial
Bookmark this article
|
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
More about...
Your opinion matters
28 votes - 49 days left ...
Related articles
Newsletter
Subscribe to get the best content related to AML delivered to your inbox