KEY TAKEAWAYS
- CPX-351 is a liposomal encapsulation of daunorubicin and cytarabine in a synergistic 1:5 molar ratio.
- In the phase III clinical trial, CPX-351 significantly improved remission frequency, overall survival, and post-transplant survival in elderly patients.
- This retrospective study assessed the 5-year follow-up results based on the European LeukemiaNet 2017 risk stratification.
- Patients who received CPX-351 exhibited a greater frequency of remission and longer median overall survival and post-transplant survival compared to those who received 7 + 3 chemotherapy.
- The safety profile of CPX-351 in patients diagnosed with adverse-risk or intermediate-risk AML was consistent with the safety profile.
- The positive results noted in this retrospective analysis reinforce the appropriateness of administering CPX-351 to elderly patients diagnosed with high-risk or secondary AML.
CPX-351, also known as Vyxeos® in Europe and the United States, is a liposomal encapsulation of two drugs, daunorubicin, and cytarabine, in a synergistic 1:5 molar ratio. In the phase III clinical trial conducted on elderly patients diagnosed with high-risk or secondary acute myeloid leukemia (AML), CPX-351 demonstrated a significant improvement in the frequency of remission, overall survival, and post-transplant survival to the standard 7 + 3 chemotherapy regimen. This retrospective study assessed the ultimate 5-year follow-up results based on the European LeukemiaNet 2017 risk stratification. Patients who received CPX-351 exhibited a greater frequency of remission (41% vs. 26% for adverse risk; 58% vs. 39% for intermediate risk) and longer median overall survival (7.59 vs. 5.52 months for adverse risk; 11.86 vs. 7.75 months for intermediate risk) and post-transplant survival (43.14 vs. 7.08 months for adverse risk; not reached vs. 13.57 months for intermediate-risk) compared to those who received 7 + 3.
It is important to note that patients with adverse-risk AML generally had poorer outcomes. The safety profile of CPX-351 in patients diagnosed with adverse-risk or intermediate-risk acute myeloid leukemia (AML) was found to be consistent with the safety profile observed in the entire study population. The incidence of premature death was comparatively reduced, and the duration of hospitalization per patient-year was shorter when treated with CPX-351 as opposed to 7 + 3 in the adverse-risk and intermediate-risk subcategories. The positive results noted in this retrospective analysis regarding CPX-351 align with the findings of the entire study cohort, thereby reinforcing the appropriateness of administering CPX-351 to this particular group of patients.
Source: https://pubmed.ncbi.nlm.nih.gov/36289532/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT01696084
Cortes JE, Lin TL, Asubonteng K, Faderl S, Lancet JE, Prebet T. 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. J Hematol Oncol. 2022 Oct 26;15(1):155. doi: 10.1186/s13045-022-01361-w. PMID: 36289532; PMCID: PMC9598030.
