Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
brief summary
The purpose of this pivotal study was to compare the efficacy of asciminib (ABL001) with that of bosutinib in the treatment of participants with chronic myeloid leukemia - chronic phase (CML-CP) having previously been treated with a minimum of two prior ATP-binding site tyrosine kinase inhibitors (TKIs).
detailed description
Participants with a diagnosis of CML-CP who had received prior treatment with 2 or more ATP binding site TKIs and were treatment failure (as per guidelines adapted from the 2013 ELN recommendations) or intolerant to the most recent TKI.
Participants were randomized in a 2:1 ratio to asciminib 40 mg BID or bosutinib 500 mg QD. Randomization was stratified by major cytogenetic response (MCyR) at screening.
Participants with documented treatment failure (as per the 2013 ELN recommendations) while on bosutinib treatment were offered the option to switch to asciminib treatment within 96 weeks after the last patient was randomized to the study.
official title
A Phase 3, Multi-center, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors