Rea com study center10/26/2022 ![]() ![]() ![]() ![]() At cutoff, treatment was ongoing in 84 (53.5%) and 15 (19.7%) pts, respectively the most common reason for discontinuation was lack of efficacy in 38 (24.2%) and 27 (35.5%) pts, respectively. They were randomized 2:1 to asciminib 40 mg twice daily or BOS 500 mg once daily, stratified by baseline MCyR status (Ph+ metaphases ≤35%).Ģ33 pts were randomized to asciminib (n=157) or BOS (n=76). The key secondary objective was to compare MMR rate at wk 96 on asciminib vs BOS.Įligible pts provided informed consent, were adults with CML-CP after ≥2 prior TKIs, with intolerance or lack of efficacy per 2013 European LeukemiaNet recommendations. After a median follow-up of 2.3 years (16.5 months’ additional follow-up since the primary analysis), we report updated efficacy and safety results (cutoff: October 6, 2021). Fewer grade ≥3 adverse events (AEs) and AEs leading to treatment discontinuation occurred on asciminib vs BOS. Major molecular response (MMR) rate at wk 24 was 25.5% on asciminib vs 13.2% on BOS the difference in MMR rates after adjusting for baseline major cytogenetic response (MCyR) was 12.2% (95% CI, 2.19%-22.30% 2-sided P=.029). In the ASCEMBL primary analysis, asciminib had superior efficacy and better safety/tolerability vs bosutinib (BOS) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) after ≥2 prior tyrosine kinase inhibitors (TKIs). Session title: Treatment and monitoring in CMLĪsciminib is the 1st BCR::ABL1 inhibitor to Specifically Target the ABL Myristoyl Pocket (STAMP). ![]()
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