Asciminib vs bosutinib in chronic-phase chronic myeloid leukemia previously treated with at least two tyrosine kinase inhibitors: longer-term follow-up of ASCEMBL
- Author(s)
- Hochhaus, A; Rea, D; Boquimpani, C; Minami, Y; Cortes, JE; Hughes, TP; Apperley, JF; Lomaia, E; Voloshin, S; Turkina, A; Kim, DW; Abdo, A; Fogliatto, LM; le Coutre, P; Sasaki, K; Kim, DDH; Saussele, S; Annunziata, M; Chaudhri, N; Chee, L; Garcia-Gutierrez, V; Kapoor, S; Allepuz, A; Quenet, S; Bedoucha, V; Mauro, MJ;
- Journal Title
- Leukemia
- Publication Type
- Research article
- Abstract
- Asciminib, the first BCR::ABL1 inhibitor that Specifically Targets the ABL Myristoyl Pocket (STAMP), is approved worldwide for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (CML-CP) treated with >/=2 prior tyrosine kinase inhibitors (TKIs). In ASCEMBL, patients with CML-CP treated with >/=2 prior TKIs were randomized (stratified by baseline major cytogenetic response [MCyR]) 2:1 to asciminib 40 mg twice daily or bosutinib 500 mg once daily. Consistent with previously published primary analysis results, after a median follow-up of 2.3 years, asciminib continued to demonstrate superior efficacy and better safety and tolerability than bosutinib. The major molecular response (MMR) rate at week 96 (key secondary endpoint) was 37.6% with asciminib vs 15.8% with bosutinib; the MMR rate difference between the arms, after adjusting for baseline MCyR, was 21.7% (95% CI, 10.53-32.95; two-sided p = 0.001). Fewer grade >/=3 adverse events (AEs) (56.4% vs 68.4%) and AEs leading to treatment discontinuation (7.7% vs 26.3%) occurred with asciminib than with bosutinib. A higher proportion of patients on asciminib than bosutinib remained on treatment and continued to derive benefit over time, supporting asciminib as a standard of care for patients with CML-CP previously treated with >/=2 TKIs.
- Publisher
- Springer Nature
- Keywords
- Adult; Humans; Tyrosine Protein Kinase Inhibitors; Follow-Up Studies; Treatment Outcome; Protein Kinase Inhibitors/therapeutic use; *Leukemia, Myeloid, Chronic-Phase; *Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy
- Department(s)
- Clinical Haematology
- PubMed ID
- 36717654
- Publisher's Version
- https://doi.org/10.1038/s41375-023-01829-9
- Open Access at Publisher's Site
https://doi.org/10.1038/s41375-023-01829-9- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2023-05-30 07:27:48
Last Modified: 2023-05-30 07:28:52