Asciminib monotherapy as frontline treatment of chronic-phase chronic myeloid leukemia: results from the ASCEND study

Asciminib is a myristoyl site BCR::ABL1 inhibitor approved for patients with chronic-phase chronic myeloid leukemia (CP-CML) failing ≥2 prior lines of therapy. The Australasian Leukaemia and Lymphoma Group conducted the Asciminib Evaluation in Newly Diagnosed CML study to assess efficacy of asciminib for newly diagnosed CP-CML. Patients commenced asciminib 40 mg twice daily. Patients with treatment failure, defined as BCR::ABL1 of >10% at 3 or 6 months, or >1% at 12 or 18 months, received either imatinib, nilotinib, or dasatinib in addition to asciminib. In patients with suboptimal response, defined as levels of 1% to 10% at 6 months, >0.1% to 1% at 12 months, or >0.01% to 1% at 18 months, the asciminib dose was increased to 80 mg twice daily. With a median follow-up of 21 months (range, 0-36), 82 of 101 patients continue asciminib. Most common reasons for treatment discontinuation were adverse events (6%), loss of response (4%), and withdrawn consent (5%). There were no deaths; 1 patient developed lymphoid blast crisis. The coprimary end points were early molecular response (BCR::ABL1 of ≤10% at 3 months), achieved in 93% (96% confidence interval [CI], 86-97%), and major molecular response by 12 months achieved in 79%; (95% CI, 70-87%), respectively. Cumulative incidence of molecular response 4.5 was 53% by 24 months. One patient had 2 cerebrovascular events; no other arterial occlusive events were reported. Asciminib as frontline CP-CML therapy leads to high rates of molecular response with excellent tolerance and a low rate of discontinuation for toxicity. This trial was registered at https://www.anzctr.org.au/ as #ACTRN12620000851965.

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Journal
Blood
Published
2024-08-05
DOI
https://doi.org/10.1182/blood.2024024657
Citations
20
Primary Topic
Chronic Myeloid Leukemia Treatments
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article
Field-Weighted Citation Impact
9.09
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article

Asciminib monotherapy as frontline treatment of chronic-phase chronic myeloid leukemia: results from the ASCEND study

David T Yeung, Alwyn Bernard D'Souza, Nicholas Viiala, Susan Branford et al.
20 citations
Blood
Chronic Myeloid Leukemia Treatments
9.09
article

Asciminib monotherapy as frontline treatment of chronic-phase chronic myeloid leukemia: results from the ASCEND study

David T Yeung, Alwyn Bernard D'Souza, Nicholas Viiala, Susan Branford, Rosemary Anne Harrup, Naranie Shanmuganathan, Carolyn Grove, David M. Ross, Cecily J. Forsyth, Timothy P. Hughes, John Reynolds, Jake Shortt, Lynette Chui Yen Chee, Steven Lane, Agnes S. M. Yong, Mannu Walia, Ilona Cunningham, Peter Browett, Andrew A Grigg, Matthew Wright, Robin Filshie
article en
20 citations

Abstract

Asciminib is a myristoyl site BCR::ABL1 inhibitor approved for patients with chronic-phase chronic myeloid leukemia (CP-CML) failing ≥2 prior lines of therapy. The Australasian Leukaemia and Lymphoma Group conducted the Asciminib Evaluation in Newly Diagnosed CML study to assess efficacy of asciminib for newly diagnosed CP-CML. Patients commenced asciminib 40 mg twice daily. Patients with treatment failure, defined as BCR::ABL1 of >10% at 3 or 6 months, or >1% at 12 or 18 months, received either imatinib, nilotinib, or dasatinib in addition to asciminib. In patients with suboptimal response, defined as levels of 1% to 10% at 6 months, >0.1% to 1% at 12 months, or >0.01% to 1% at 18 months, the asciminib dose was increased to 80 mg twice daily. With a median follow-up of 21 months (range, 0-36), 82 of 101 patients continue asciminib. Most common reasons for treatment discontinuation were adverse events (6%), loss of response (4%), and withdrawn consent (5%). There were no deaths; 1 patient developed lymphoid blast crisis. The coprimary end points were early molecular response (BCR::ABL1 of ≤10% at 3 months), achieved in 93% (96% confidence interval [CI], 86-97%), and major molecular response by 12 months achieved in 79%; (95% CI, 70-87%), respectively. Cumulative incidence of molecular response 4.5 was 53% by 24 months. One patient had 2 cerebrovascular events; no other arterial occlusive events were reported. Asciminib as frontline CP-CML therapy leads to high rates of molecular response with excellent tolerance and a low rate of discontinuation for toxicity. This trial was registered at https://www.anzctr.org.au/ as #ACTRN12620000851965.

BloodVol. 144(19)
South Australia Pathology (AU), The University of Sydney (AU), University of Tasmania (AU), Royal Adelaide Hospital (AU), The Royal Melbourne Hospital (AU), University of Auckland (NZ), The University of Queensland (AU), The University of Melbourne (AU), Flinders University (AU), University of South Australia (AU), The University of Western Australia (AU), QIMR Berghofer Medical Research Institute (AU), Royal Brisbane and Women's Hospital (AU), Royal Perth Hospital (AU), Concord Repatriation General Hospital (AU), Austin Hospital (AU), Peter MacCallum Cancer Centre (AU), Fiona Stanley Hospital (AU), Liverpool Hospital (AU), Wellington Hospital (NZ), Gosford Hospital (AU), Auckland City Hospital (NZ), The Alfred Hospital (AU), Sir Charles Gairdner Hospital (AU), Flinders Medical Centre (AU), Royal Hobart Hospital (AU), UNSW Sydney (AU), St Vincent's Hospital Melbourne (AU), Monash Health (AU), South Australian Health and Medical Research Institute (AU), Centre for Cancer Biology (AU), Australasian Leukaemia and Lymphoma Group (AU), Alfred Health (AU), Monash University (AU), The University of Adelaide (AU), University of Otago (NZ)
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Openalex Percentile: Top 2%
Chronic Myeloid Leukemia Treatments
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