6/28/23, 12:45 AM ASCEMBL Pathway Feedback Search Clinical Topics Home Studies ASCEMBL ASCEMBL Disease Chronic myeloid leukemia 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 N = 233 48.0% male 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) https://web.pathway.md/studies/recFyTiRHWC24ftsO 1/2 6/28/23, 12:45 AM ASCEMBL Pathway Primary outcome Major molecular response rate at week 24 25.5 % 25.5 19.1 % 13.2 12.8 % Significant increase 6.4 % NNT = 8 0.0 % Asciminib Bosutinib 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 R a, 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. Open reference URL https://web.pathway.md/studies/recFyTiRHWC24ftsO 2/2