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Promising Results for CPX-351 in Acute Myeloid Leukemia (AML) Patients

Strategic Insights

— 1 min read

Investigators reported encouraging interim data from a Phase 2 clinical trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in patients aged 60-75 with untreated acute myeloid leukemia (AML). The study, presented at the 51st American Society of Hematology (ASH) Annual Meeting, compared CPX-351 to the conventional "7+3" therapy and observed a complete remission (CR) rate of 61.4% for CPX-351 versus 50.0% for "7+3". The safety profile of CPX-351 was generally comparable to "7+3", with a longer time to recovery of neutrophils and platelets associated with CPX-351.

Key Takeaways:

  • The interim data from the Phase 2 clinical trial of CPX-351 in AML patients showed a promising CR rate of 61.4% compared to 50.0% for "7+3" therapy.
  • The safety profile of CPX-351 was generally comparable to "7+3" therapy, with a longer time to recovery of neutrophils and platelets associated with CPX-351.
  • The fully enrolled Phase 2 study treated 126 patients with newly diagnosed AML, who were randomized to receive either CPX-351 or "7+3" therapy.
  • The primary endpoint of the study is complete remission (CR) rate, and secondary endpoints include duration of CR, event-free survival, survival at 12 months, and safety and tolerability.
  • Pre-clinical data presented at the ASH Meeting showed a 2.4-fold increase in leukemia-selective cytoxicity with CPX-351 compared to free cytarabine/daunorubicin.

Statistics:

  • The CR rate for CPX-351 was 61.4%, compared to 50.0% for "7+3" therapy.
  • The safety profile of CPX-351 was generally comparable to "7+3" therapy, with a longer time to recovery of neutrophils and platelets associated with CPX-351 (approximately 7 days longer).
  • The fully enrolled Phase 2 study treated 126 patients with newly diagnosed AML.
  • The study participants were randomized (2:1) to receive either CPX-351 or "7+3" therapy.
  • The primary endpoint of the study is complete remission (CR) rate.

Sources:

  • [1] Celator Pharmaceuticals: Interim Safety and Efficacy Data Presented at 51st American Society of Hematology (ASH) Annual Meeting (ASH Abstract # 1033)
  • [2] Celator Pharmaceuticals: Pre-clinical Data Presented at 51st American Society of Hematology (ASH) Annual Meeting (ASH Abstract # 2071)
  • [3] Blood Weekly: Copyright 2009, Blood Weekly via NewsRx.com

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