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@article{2424062,
author = {Hochhaus, Andreas and Wang, Jianxiang and Kim, DongandWook and Kim, Dennis Dong Hwan and Mayer, Jiří and Goh, YeowandTee and Philipp, le Coutre and Takahashi, Naoto and Kim, Inho and Etienne, Gabriel and Andorsky, David and Issa, Ghayas C and Larson, Richard A and Bombaci, Felice and Kapoor, Shruti and McCulloch, Tracey and Malek, Kamel and Yau, Lillian and Ifrah, Sophie and Hoch, Matthias and Cortes, Jorge E and Hughes, Timothy P},
article_location = {Waltham},
doi = {http://dx.doi.org/10.1056/NEJMoa2400858},
keywords = {Chronic Myeloid Leukemia; Asciminib},
language = {eng},
issn = {0028-4793},
journal = {New England Journal of Medicine},
title = {Asciminib in Newly Diagnosed Chronic Myeloid Leukemia},
url = {https://www.nejm.org/doi/10.1056/NEJMoa2400858},
year = {2024}
}
TY - JOUR
ID - 2424062
AU - Hochhaus, Andreas - Wang, Jianxiang - Kim, Dong-Wook - Kim, Dennis Dong Hwan - Mayer, Jiří - Goh, Yeow-Tee - Philipp, le Coutre - Takahashi, Naoto - Kim, Inho - Etienne, Gabriel - Andorsky, David - Issa, Ghayas C - Larson, Richard A - Bombaci, Felice - Kapoor, Shruti - McCulloch, Tracey - Malek, Kamel - Yau, Lillian - Ifrah, Sophie - Hoch, Matthias - Cortes, Jorge E - Hughes, Timothy P
PY - 2024
TI - Asciminib in Newly Diagnosed Chronic Myeloid Leukemia
JF - New England Journal of Medicine
SP - 1-14
EP - 1-14
PB - Massachussetts Medical Society
SN - 00284793
KW - Chronic Myeloid Leukemia
KW - Asciminib
UR - https://www.nejm.org/doi/10.1056/NEJMoa2400858
N2 - Background Patients with newly diagnosed chronic myeloid leukemia (CML) need long-term therapy with high efficacy and safety. Asciminib, a BCR::ABL1 inhibitor specifically targeting the ABL myristoyl pocket, may offer better efficacy and safety and fewer side effects than currently available frontline ATP-competitive tyrosine kinase inhibitors (TKIs). Methods In a phase 3 trial, patients with newly diagnosed CML were randomly assigned in a 1:1 ratio to receive either asciminib (80 mg once daily) or an investigator-selected TKI, with randomization stratified by European Treatment and Outcome Study long-term survival score category (low, intermediate, or high risk) and by TKI selected by investigators before randomization (including imatinib and second-generation TKIs). The primary end points were major molecular response (defined as BCR::ABL1 transcript levels <= 0.1% on the International Scale [IS]) at week 48, for comparisons between asciminib and investigator-selected TKIs and between asciminib and investigator-selected TKIs in the prerandomization-selected imatinib stratum. Results A total of 201 patients were assigned to receive asciminib and 204 to receive investigator-selected TKIs. The median follow-up was 16.3 months in the asciminib group and 15.7 months in the investigator-selected TKI group. A major molecular response at week 48 occurred in 67.7% of patients in the asciminib group, as compared with 49.0% in the investigator-selected TKI group (difference, 18.9 percentage points; 95% confidence interval [CI], 9.6 to 28.2; adjusted two-sided P<0.001]), and in 69.3% of patients in the asciminib group as compared with 40.2% in the imatinib group within the imatinib stratum (difference, 29.6 percentage points; 95% CI, 16.9 to 42.2; adjusted two-sided P<0.001). The percentage of patients with a major molecular response at week 48 was 66.0% with asciminib and 57.8% with TKIs in the second-generation TKI stratum (difference, 8.2 percentage points; 95% CI, -5.1 to 21.5). Adverse events of grade 3 or higher and events leading to discontinuation of the trial regimen were less frequent with asciminib (38.0% and 4.5%, respectively) than with imatinib (44.4% and 11.1%) and second-generation TKIs (54.9% and 9.8%). Conclusions In this trial comparing asciminib with investigator-selected TKIs and imatinib, asciminib showed superior efficacy and a favorable safety profile in patients with newly diagnosed chronic-phase CML. Direct comparison between asciminib and second-generation TKIs was not a primary objective.
ER -
HOCHHAUS, Andreas, Jianxiang WANG, Dong-Wook KIM, Dennis Dong Hwan KIM, Jiří MAYER, Yeow-Tee GOH, le Coutre PHILIPP, Naoto TAKAHASHI, Inho KIM, Gabriel ETIENNE, David ANDORSKY, Ghayas C ISSA, Richard A LARSON, Felice BOMBACI, Shruti KAPOOR, Tracey MCCULLOCH, Kamel MALEK, Lillian YAU, Sophie IFRAH, Matthias HOCH, Jorge E CORTES and Timothy P HUGHES. Asciminib in Newly Diagnosed Chronic Myeloid Leukemia. \textit{New England Journal of Medicine}. Waltham: Massachussetts Medical Society, 2024, p.~1-14. ISSN~0028-4793. Available from: https://dx.doi.org/10.1056/NEJMoa2400858.
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