• Medientyp: E-Artikel
  • Titel: Asciminib vs bosutinib in chronic-phase chronic myeloid leukemia previously treated with at least two tyrosine kinase inhibitors: longer-term follow-up of ASCEMBL
  • Beteiligte: Hochhaus, Andreas; Réa, Delphine; Boquimpani, Carla; Minami, Yosuke; Cortes, Jorge E.; Hughes, Timothy P.; Apperley, Jane F.; Lomaia, Elza; Voloshin, Sergey; Turkina, Anna; Kim, Dong-Wook; Abdo, Andre; Fogliatto, Laura Maria; le Coutre, Philipp; Sasaki, Koji; Kim, Dennis Dong Hwan; Saussele, Susanne; Annunziata, Mario; Chaudhri, Naeem; Chee, Lynette; García-Gutiérrez, Valentin; Kapoor, Shruti; Allepuz, Alex; Quenet, Sara; [...]
  • Erschienen: Springer Science and Business Media LLC, 2023
  • Erschienen in: Leukemia, 37 (2023) 3, Seite 617-626
  • Sprache: Englisch
  • DOI: 10.1038/s41375-023-01829-9
  • ISSN: 0887-6924; 1476-5551
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  • Beschreibung: AbstractAsciminib, 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.