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Asciminib vs bosutinib in chronic-phase chronic myeloid leukemia previously treated with at least two tyrosine kinase inhibitors: longer-term follow-up of ASCEMBL

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...

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Main Authors: Hochhaus, Andreas (Author) , Réa, Delphine (Author) , Boquimpani, Carla (Author) , Minami, Yosuke (Author) , Cortés, Jorge Eduardo (Author) , Hughes, Timothy P. (Author) , Apperley, Jane F. (Author) , Lomaia, Elza (Author) , Voloshin, Sergey (Author) , Turkina, Anna (Author) , Kim, Dong-Wook (Author) , Abdo, Andre (Author) , Fogliatto, Laura Maria (Author) , le Coutre, Philipp (Author) , Sasaki, Koji (Author) , Kim, Dennis Dong Hwan (Author) , Saußele, Susanne (Author) , Annunziata, Mario (Author) , Chaudhri, Naeem (Author) , Chee, Lynette (Author) , García-Gutiérrez, Valentin (Author) , Kapoor, Shruti (Author) , Allepuz, Alex (Author) , Quenet, Sara (Author) , Bédoucha, Véronique (Author) , Mauro, Michael J. (Author)
Format: Article (Journal)
Language:English
Published: March 2023
In: Leukemia
Year: 2023, Volume: 37, Issue: 3, Pages: 617-626
ISSN:1476-5551
DOI:10.1038/s41375-023-01829-9
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1038/s41375-023-01829-9
Verlag, kostenfrei, Volltext: https://www.nature.com/articles/s41375-023-01829-9
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Author Notes:Andreas Hochhaus, Delphine Réa, Carla Boquimpani, Yosuke Minami, Jorge E. Cortes, Timothy P. Hughes, Jane F. Apperley, Elza Lomaia, Sergey Voloshin, Anna Turkina, Dong-Wook Kim, Andre Abdo, Laura Maria Fogliatto, Philipp le Coutre, Koji Sasaki, Dennis Dong Hwan Kim, Susanne Saussele, Mario Annunziata, Naeem Chaudhri, Lynette Chee, Valentin García-Gutiérrez, Shruti Kapoor, Alex Allepuz, Sara Quenet, Véronique Bédoucha and Michael J. Mauro

MARC

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520 |a 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. 
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