ASCEMBL
Trial question
What is the role of asciminib in patients with chronic-phase chronic myeloid leukemia previously treated with ≥ 2 TKIs?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 233
233 patients (120 female, 113 male)
Inclusion criteria: adult patients with chronic-phase chronic myeloid leukemia previously treated with ≥ 2 TKIs
Key exclusion criteria: cardiac or cardiac repolarization abnormality; uncontrolled diabetes; pulmonary hypertension; acute or chronic liver disease; history of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
Interventions
N=157 asciminib (at a dose of 40 mg BID)
N=76 bosutinib (at a dose of 500 mg once daily)
Primary outcome
Major molecular response rate at week 24
25.5
13.2
25.5 %
19.1 %
12.8 %
6.4 %
0.0 %
Asciminib
Bosutinib
Significant increase ▲
NNT = 8
Significant increase in major molecular response rate at week 24 (25.5% vs. 13.2%; AD 12.2%, 95% CI 2.19 to 22.3)
Secondary outcomes
Significant increase in major molecular response rate at week 96 (37.6% vs. 15.8%; AD 21.74%, 95% CI 10.53 to 32.95)
Significant increase in complete cytogenic response rate at week 96 (39.8% vs. 16.1%; AD 23.9%, 95% CI 10.3 to 37.4)
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients with chronic-phase chronic myeloid leukemia previously treated with ≥ 2 TKIs, asciminib was superior to bosutinib with respect to major molecular response rate at week 24.
Reference
Andreas Hochhaus, Delphine Réa, Carla Boquimpani et al. Asciminib vs bosutinib in chronic-phase chronic myeloid leukemia previously treated with at least two tyrosine kinase inhibitors: longer-term follow-up of ASCEMBL. Leukemia. 2023 Mar;37(3):617-626.
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