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CPX-351 vs FLAG-Ida: Post-hoc subgroup analysis of the UK NCRI AML19 trial
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An exploratory, post-hoc subgroup analysis of the UK NCRI AML19 trial (ISRCTN78449203) compared the efficacy and safety of CPX-351 (n = 30) with FLAG-Ida (n = 29) in patients with ND HR-AML/MDS and MDS-related gene mutations. Results were presented during the 66th American Society of Hematology (ASH) Annual Meeting and Exposition by Mehta P.1 |
| Key learnings |
| CPX-351 resulted in longer mOS (38.4 vs 16.3 months; p = 0.008), mRFS (33.1 vs 18.3 months; p = 0.024), and mEFS (34.0 vs 5.9 months; p = 0.062) vs FLAG-Ida. |
| The ORR (CR+ CRi) was 50% vs 62% with CPX-351 vs FLAG-Ida after induction C1 and 69% vs 79% after C2. Among patients in first response, CPX-351 led to longer post-HSCT mOS (NR vs 18.1 months; p = 0.042) than FLAG-Ida. |
| CPX-351 was associated with lower Grade ≥3 AEs (70% vs 90%), SAEs (10% vs 76%), and AEs leading to death (7% vs 14%) vs FLAG-Ida. |
| This post-hoc analysis showed that CPX-351 improved mOS, mRFS, and post-HSCT OS. However, the study is limited by its small sample size, exploratory nature, and unadjusted p-values for multiplicity, warranting further validation in larger studies. |
Abbreviations: AE, adverse event; AML, acute myeloid leukemia; ASH, American Society of Hematology; C, cycle; CR, complete response; CRi, CR with incomplete neutrophil or platelet recovery; EFS, event-free survival; FLAG-Ida, fludarabine, cytarabine, granulocyte-colony stimulating factor, and idarubicin; HR, high-risk; HSCT, hematopoietic stem cell transplantation; m, median; MDS, myelodysplastic syndrome; ND, newly diagnosed; NR, not reached; ORR, overall response rate; OS, overall survival; RFS, relapse-free survival; SAE, serious AE.
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