Asciminib

(Scemblix®)

Asciminib

Drug updated on 5/17/2024

Dosage FormFilm-coated tablet (oral; 20 mg, 40 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, previously treated with two or more tyrosine kinase inhibitors (TKIs).
  • Indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase with the T315I mutation.

Summary
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  • Asciminib (Scemblix) is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, previously treated with two or more tyrosine kinase inhibitors (TKIs), and those carrying the T315I mutation.
  • A systematic review/meta-analysis was conducted to evaluate Scemblix's efficacy and safety compared to other TKIs in treating this specific patient population.
  • The major molecular response rates within 6 months of treatment showed that Scemblix had a moderate efficacy range from 23.3% to 25.5%, positioning it between ponatinib, which had the highest variability at 19.0% to 66.7%, and bosutinib, which had the lowest rate at 13.2%.
  • In terms of achieving complete cytogenetic response rates at six months, Scemblix demonstrated reliable efficacy with a consistent rate range of 38.7% to 40.8%. This places it above bosutinib's lower CCyR rate ranging from 18% to 24% but potentially below ponatinib’s wide-ranging effectiveness from 21.4% to 64.8%.
  • While detailed comparisons were not specified in this study, there is an emphasis on further research needed to establish optimal treatments for patients within this category, i.e., CP-CML who have received two or more prior TKIs, indicating potential gaps regarding safety data comparison among these drugs including Scemblix.
  • The reviewed study highlights a significant subgroup: those having been treated with two or more prior TKIs, suggesting its focus on a resistant or treatment-experienced group where Scemblix serves as one therapeutic option, thus emphasizing its role in managing challenging CML cases.

Product Monograph / Prescribing Information

Document TitleYearSource
Scemblix (asciminib) Prescribing Information.2023Novartis Pharmaceuticals Corporation, East Hanover, NJ

Systematic Reviews / Meta-Analyses