Impact of <i>ASXL1</i> at diagnosis in patients with CML receiving frontline potent TKIs: high risk of kinase domain mutations

N Naranie Shanmuganathan (1Department of Haematology, Royal Adelaide Hospital and SA Pathology, Adelaide, Australia) D David T. Yeung (Haematology, Royal Adelaide Hospital, Adelaide, SA, Australia) C Carol Wadham (2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia) A Adelina Fernandes (2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia) M Muneeza Maqsood (2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia) N NurHezrin Shahrin (2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia) V Verity Saunders (4Precision Cancer Medicine Theme, South Australian Health and Medical Research Institute, Adelaide, Australia) R Rosalie R. Kenyon (2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia) M Ming Lin (Institute of Materials Research and Engineering (IMRE), Agency for Science, Technology and Research (A*STAR), 2 Fusionopolis Way, Innovis #08-03, Singapore 138634, Singapore) J John Toubia (Centre for Cancer Biology, College of Health, Adelaide University and SA Pathology) J Joe McConnell (2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia) D Dominic Kaczorowski (2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia) D David M. Ross (21Haematology Directorate, SA Pathology, Royal Adelaide Hospital and Flinders Medical Centre, Adelaide, Australia) A Agnes S. M. Yong (4Precision Cancer Medicine Theme, South Australian Health and Medical Research Institute, Adelaide, Australia) L Lynette Chee (6Australasian Leukemia and Lymphoma Group, Melbourne, Australia) J Jake Shortt (6Australasian Leukemia and Lymphoma Group, Melbourne, Australia) N Nicholas Viiala (6Australasian Leukemia and Lymphoma Group, Melbourne, Australia) J Jodi Braley (2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia) C Chung Hoow Kok (Centre for Cancer Biology, College of Health, Adelaide University and SA Pathology) T Timothy P. Hughes (2Precision Cancer Medicine Theme, South Australian Health and Medical Research Institute and University of Adelaide, Adelaide, Australia) S Susan Branford (2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia)

Abstract

Abstract Genomic profiling in patients with chronic-phase chronic myeloid leukemia (CP-CML) demonstrated somatic variants in blood cancer-related gene variants (CGVs) and rearrangements associated with the formation of the Philadelphia chromosome (Ph-associated rearrangements) at diagnosis, collectively termed additional genetic abnormalities (AGAs). AGAs had a negative impact on failure-free survival (FFS) and molecular response in imatinib-treated patients. We investigated whether treatment with more potent therapies could overcome the negative impact of AGAs at diagnosis. Targeted RNA-based next-generation sequencing was performed on diagnostic samples of 315 patients consecutively enrolled in 4 clinical trials of frontline potent tyrosine kinase inhibitors (TKIs) in CP-CML. AGAs were present in 34% of patients at diagnosis, including 20% harboring CGVs and 18% with Ph-associated rearrangements (4% had both). Although the negative impact of Ph-associated rearrangements was overcome by more potent inhibitors, patients with CGVs continued to experience inferior outcomes. This result was largely attributable to patients with ASXL1 variants, observed in 7% overall. Patients harboring ASXL1 variants also had inferior outcomes compared with those with wild-type ASXL1 in terms of 12-month major molecular response (55% vs 83%; P = .001), 2-year FFS (61% vs 91%; P &amp;lt; .001), and notably, the development of treatment-emergent BCR::ABL1 kinase domain mutations at 2 years (35% vs 1%; P &amp;lt; .001). In multivariable models, both CGVs and ASXL1 variants were predictors of each outcome. Treatment with frontline potent TKIs overcame the negative impact of Ph-associated rearrangements observed with frontline imatinib. However, inferior outcomes were still associated with the presence of CGVs. The acquisition of TKI-resistant BCR::ABL1 mutations was almost exclusively associated with mutated ASXL1 at diagnosis.

Article Details

Journal Blood
Volume / Issue Vol. 146, Issue 23
Published December 04, 2025
Pages 2821-2832
ISSN 0006-4971
Publisher Elsevier BV

Journal Info

Blood

Elsevier BV

ISSN: 0006-4971 Health Sciences

Authors (21)

N

Naranie Shanmuganathan

1Department of Haematology, Royal Adelaide Hospital and SA Pathology, Adelaide, Australia

D

David T. Yeung

Haematology, Royal Adelaide Hospital, Adelaide, SA, Australia

C

Carol Wadham

2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia

A

Adelina Fernandes

2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia

M

Muneeza Maqsood

2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia

N

NurHezrin Shahrin

2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia

V

Verity Saunders

4Precision Cancer Medicine Theme, South Australian Health and Medical Research Institute, Adelaide, Australia

R

Rosalie R. Kenyon

2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia

M

Ming Lin

Institute of Materials Research and Engineering (IMRE), Agency for Science, Technology and Research (A*STAR), 2 Fusionopolis Way, Innovis #08-03, Singapore 138634, Singapore

J

John Toubia

Centre for Cancer Biology, College of Health, Adelaide University and SA Pathology

J

Joe McConnell

2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia

D

Dominic Kaczorowski

2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia

D

David M. Ross

21Haematology Directorate, SA Pathology, Royal Adelaide Hospital and Flinders Medical Centre, Adelaide, Australia

A

Agnes S. M. Yong

4Precision Cancer Medicine Theme, South Australian Health and Medical Research Institute, Adelaide, Australia

L

Lynette Chee

6Australasian Leukemia and Lymphoma Group, Melbourne, Australia

J

Jake Shortt

6Australasian Leukemia and Lymphoma Group, Melbourne, Australia

N

Nicholas Viiala

6Australasian Leukemia and Lymphoma Group, Melbourne, Australia

J

Jodi Braley

2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia

C

Chung Hoow Kok

Centre for Cancer Biology, College of Health, Adelaide University and SA Pathology

T

Timothy P. Hughes

2Precision Cancer Medicine Theme, South Australian Health and Medical Research Institute and University of Adelaide, Adelaide, Australia

S

Susan Branford

2Department of Genetics and Molecular Pathology, SA Pathology, Adelaide, Australia