TY - JOUR
T1 - Asciminib vs bosutinib in chronic-phase chronic myeloid leukemia previously treated with at least two tyrosine kinase inhibitors
T2 - longer-term follow-up of ASCEMBL
AU - Hochhaus, Andreas
AU - Réa, Delphine
AU - Boquimpani, Carla
AU - Minami, Yosuke
AU - Cortes, Jorge E.
AU - Hughes, Timothy P.
AU - Apperley, Jane F.
AU - Lomaia, Elza
AU - Voloshin, Sergey
AU - Turkina, Anna
AU - Kim, Dong Wook
AU - Abdo, Andre
AU - Fogliatto, Laura Maria
AU - le Coutre, Philipp
AU - Sasaki, Koji
AU - Kim, Dennis Dong Hwan
AU - Saussele, Susanne
AU - Annunziata, Mario
AU - Chaudhri, Naeem
AU - Chee, Lynette
AU - García-Gutiérrez, Valentin
AU - Kapoor, Shruti
AU - Allepuz, Alex
AU - Quenet, Sara
AU - Bédoucha, Véronique
AU - Mauro, Michael J.
N1 - Publisher Copyright:
© 2023, The Author(s).
PY - 2023/3
Y1 - 2023/3
N2 - 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. [Figure not available: see fulltext.].
AB - 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. [Figure not available: see fulltext.].
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U2 - 10.1038/s41375-023-01829-9
DO - 10.1038/s41375-023-01829-9
M3 - Article
C2 - 36717654
AN - SCOPUS:85147020701
SN - 0887-6924
VL - 37
SP - 617
EP - 626
JO - Leukemia
JF - Leukemia
IS - 3
ER -