Key clinical point: At 5 years of follow-up, a fixed combination of daunorubicin and cytarabine (CPX-351) vs standard chemotherapy with cytarabine for 7 days and daunorubicin for 3 days ( 7+3) improved overall survival (OS) in older patients with newly diagnosed high-risk or secondary acute myeloid leukemia (AML).
Major finding: Favorable difference in median OS in favor of CPX-351 vs 7+3 group was maintained (hazard ratio, 0.70; 95% confidence interval [CI], 0.55-0.91). At 5 years, survival estimates were higher for CPX-351 vs 7+3 (18% [95% CI, 12%-25%] vs 8% [95% CI, 4%-13%]). Overall, 5% of deaths in both groups were considered related to the study treatment.
Study details: Findings are the final 5-year follow-up results of a phase 3 trial including 309 patients aged 60-75 years with newly diagnosed high-risk or secondary AML. Patients were randomly assigned to either CPX-351 (n=153) or 7+3 chemotherapy (n=156).
Disclosures: This study was supported by Jazz Pharmaceuticals. The lead author reported consulting for various sources. Other authors reported ties with various pharmaceutical companies including Jazz Pharmaceuticals.
Source: Lancet JE et al. Lancet Haematol. 2021 Jul. doi: 10.1016/S2352-3026(21)00134-4 .