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New Indication: Asciminib for CML

New Indication: Asciminib for CML
Study:
  • Phase 1, dose-escalation study
  • Refractory CML pts with prior at least two ATP-competitive TKIs
  • Asciminib once or twice daily (10 to 200 mg)
Efficacy:
  • 34 (92%) with a hematologic relapse => complete hematologic response
  • 31 (54%) without a complete cytogenetic response => complete cytogenetic response
  • 12 months major molecular response => 48%
  • 12 months major molecular response with T315I mutation =>28%
  • Ongoing molecular response 40/44 patients
Safety:
  • Grade >=3 AEs: All 60%. Lipase increased 10%, thrombocytopenia 9.3%, hypertension 9.3%, neutropenia 7.3%, anemia 7.3%.

N Engl J Med 2019; 381:2315-2326

Hughes TP., et al. Asciminib in Chronic Myeloid Leukemia after ABL Kinase Inhibitor Failure

https://doi.org/10.1056/nejmoa1902328

Reviewed by Hasan Cagri Yildirim, MD on Sep 30, 2021

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