Asciminib approved for patients with Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) in chronic phase who have previously been treated with 2 or more TKIs, and for those with Ph-positive CML in chronic phase with a T315I mutation.
Scemblix for patients with Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) in chronic phase who have previously been treated with 2 or more TKIs.
ASCEMBL enrolled a total of 233 patients, who were randomized 2:1 to receive either asciminib at a twice-daily dose of 40 mg or bosutinib at a once-daily dose of 500 mg.
Patients were stratified based on major cytogenetic response status, and treatment was continued until intolerable toxicity or treatment failure.
Aasciminib elicited a molecular response (MMR) rate of 25% at 24 weeks vs 13% with bosutinib in this refractory patient population.
The complete cytogenetic responses elicited at 24 weeks in the investigative and control arms were 41% and 24%, respectively.
At 48 weeks, the MMR rate was 29% in those who received asciminib vs 13% in those who received bosutinib.
The number of patients who discontinued treatment because of toxicities was found to be three times lower with asciminib vs bosutinib, at 7% and 25%, respectively.
Adverse effects: upper respiratory tract infections and musculoskeletal pain, a decrease in platelet and neutrophil counts, a decrease in hemoglobin, and an increase in triglycerides, creatine kinase and alanine aminotransferase.
Administered asciminib at a twice-daily dose of 200 mg.
Forty-two percent of patients who received asciminib achieved MMR by 24 weeks; 49% of patients achieved MMR by 96 weeks.
The median duration of treatment was 108 weeks.