Key clinical point: Asciminib showed superior efficacy and a favorable safety profile compared with bosutinib in patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant or intolerant to at least 2 prior tyrosine kinase inhibitor (TKI) therapies.
Major finding: The rates of major molecular response (MMR) at week 24 in patients receiving asciminib and bosutinib were 25.5% and 13.2%, respectively (difference 12.2%; P = .029). Bosutinib vs. asciminib arms had a more frequent occurrence of grade 3 or higher adverse events (AEs; 60.5% vs. 50.6%) and AEs leading to treatment discontinuation (21.1% vs. 5.8%).
Study details: Findings are from the phase 3 ASCEMBL trial including 233 adult patients with CML-CP previously treated with at least 2 TKIs randomly assigned to receive either 40 mg asciminib twice daily or 500 mg bosutinib once daily.
Disclosures: This study was sponsored and funded by Novartis Pharmaceuticals Corporation. Some investigators including, the lead author, reported ties with various pharmaceutical companies, including Novartis.
Source: Rea D et al. Blood. 2021 Aug 18. doi: 10.1182/blood.2020009984 .