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The New England Journal of MedicineAsciminib in Newly Diagnosed Chronic Myeloid Leukemia

Asciminib shows promise in enhancing major molecular response rates and reducing severe adverse events in newly diagnosed chronic myeloid leukemia, potentially influencing future CML treatment protocols.

Asciminib, a novel BCR::ABL1 inhibitor, was evaluated in a phase 3 trial for its efficacy and safety in patients with newly diagnosed chronic myeloid leukemia (CML) compared to traditional tyrosine kinase inhibitors (TKIs) such as imatinib and second-generation TKIs. This study highlights asciminib’s potential benefits in achieving major molecular response and managing adverse events, which are crucial for long-term therapy in CML patients.

Study Design:

  • Participants: 405 patients with newly diagnosed CML
  • Randomization: 1:1 ratio to receive either asciminib (80 mg once daily) or an investigator-selected TKI
  • Stratification: Based on European Treatment and Outcome Study long-term survival score category (low, intermediate, or high risk) and TKI selected before randomization
  • Primary End Points: Major molecular response (BCR::ABL1 transcript levels ≤0.1% IS) at week 48

Key Findings:

  • Major molecular response at week 48:
    • Asciminib group: 67.7%
    • Investigator-selected TKI group: 49.0% (Difference: 18.9 percentage points; 95% CI: 9.6 to 28.2; P<0.001)
  • Major molecular response within the imatinib stratum:
    • Asciminib group: 69.3%
    • Imatinib group: 40.2% (Difference: 29.6 percentage points; 95% CI: 16.9 to 42.2; P<0.001)
  • Major molecular response in the second-generation TKI stratum:
    • Asciminib group: 66.0%
    • TKI group: 57.8% (Difference: 8.2 percentage points; 95% CI: −5.1 to 21.5)
  • Adverse events of grade 3 or higher and discontinuation rates:
    • Asciminib: 38.0% (grade 3 or higher), 4.5% (discontinuation)
    • Imatinib: 44.4% (grade 3 or higher), 11.1% (discontinuation)
    • Second-generation TKIs: 54.9% (grade 3 or higher), 9.8% (discontinuation)

HCN Medical Memo
Asciminib represents a significant advancement in the management of newly diagnosed CML, providing higher rates of major molecular response and fewer severe adverse events compared to traditional TKIs. This study may justify the potential for asciminib to become a preferred option in the frontline treatment of CML.

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