Asciminib remained superior vs bosutinib in late-line CML-CP after nearly 4 years of follow-up in ASCEMBL

The efficacy of and disease control afforded by tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia in chronic phase (CML-CP) have led to increased longevity and thus the continued pursuit of alternative therapies that are efficacious and maximize tolerability. The 24- and 96-week analyses from ASCEMBL demonstrated superior efficacy, safety, and tolerability of asciminib when compared with bosutinib in later-line therapy, thereby meeting the primary and key secondary objectives. With nearly 4 years of follow-up, data from ASCEMBL continued to demonstrate the superior efficacy, safety, and tolerability of asciminib over bosutinib. At week 156, the major molecular response (MMR) rates remained higher with asciminib (33.8%) than with bosutinib (10.5%); the difference in MMR rates between arms, after adjusting for baseline major cytogenetic response, was 23.2% (95% confidence interval, 13.14-33.18; 2-sided P < .001). Asciminib continued to cause fewer grade ≥3 adverse events (AEs; 59.6% vs 68.4%) and fewer AEs that led to treatment discontinuation (8.3% vs 27.6%) than bosutinib. This updated analysis also includes patients who switched to asciminib because of a lack of efficacy with bosutinib. Two of the 25 patients who switched achieved MMR by the end of study, suggesting that earlier incorporation of asciminib, before other TKIs, may improve responses, albeit modestly. These long-term results further solidify asciminib as the therapy of choice for patients with CML-CP who were previously treated with ≥2 previous TKIs. This trial was registered at clinicaltrials.gov as #NCT03106779.

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Publication Details

Journal
Blood Advances
Published
2025-05-07
DOI
https://doi.org/10.1182/bloodadvances.2025016042
Citations
6
Primary Topic
Chronic Myeloid Leukemia Treatments
Type
article
Field-Weighted Citation Impact
10.62

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article

Asciminib remained superior vs bosutinib in late-line CML-CP after nearly 4 years of follow-up in ASCEMBL

Anna Turkina, Naeem Chaudhri, Susanne Saußele, Jörge E. Cortes et al.
6 citations
Blood Advances
Chronic Myeloid Leukemia Treatments
10.62
article

Asciminib remained superior vs bosutinib in late-line CML-CP after nearly 4 years of follow-up in ASCEMBL

Anna Turkina, Naeem Chaudhri, Susanne Saußele, Jörge E. Cortes, Michael J. Mauro, S. S. Kapoor, Koji Sasaki, Mario Annunziata, Andreas Hochhaus, Valentín García‐Gutiérrez, Philipp le Coutre, André Abdo, Sergey Voloshin, Carla Boquimpani, Timothy P. Hughes, Laura Fogliatto, Delphine Réa, Lynette Chui Yen Chee, Yosuke Minami, Jane F. Apperley, Elza Lomaia, Dennis Dong Hwan Kim, Vishal Dhamal, Dong‐Wook Kim, Noemi Espurz-Abad
article en
6 citations

Abstract

The efficacy of and disease control afforded by tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia in chronic phase (CML-CP) have led to increased longevity and thus the continued pursuit of alternative therapies that are efficacious and maximize tolerability. The 24- and 96-week analyses from ASCEMBL demonstrated superior efficacy, safety, and tolerability of asciminib when compared with bosutinib in later-line therapy, thereby meeting the primary and key secondary objectives. With nearly 4 years of follow-up, data from ASCEMBL continued to demonstrate the superior efficacy, safety, and tolerability of asciminib over bosutinib. At week 156, the major molecular response (MMR) rates remained higher with asciminib (33.8%) than with bosutinib (10.5%); the difference in MMR rates between arms, after adjusting for baseline major cytogenetic response, was 23.2% (95% confidence interval, 13.14-33.18; 2-sided P < .001). Asciminib continued to cause fewer grade ≥3 adverse events (AEs; 59.6% vs 68.4%) and fewer AEs that led to treatment discontinuation (8.3% vs 27.6%) than bosutinib. This updated analysis also includes patients who switched to asciminib because of a lack of efficacy with bosutinib. Two of the 25 patients who switched achieved MMR by the end of study, suggesting that earlier incorporation of asciminib, before other TKIs, may improve responses, albeit modestly. These long-term results further solidify asciminib as the therapy of choice for patients with CML-CP who were previously treated with ≥2 previous TKIs. This trial was registered at clinicaltrials.gov as #NCT03106779.

Blood AdvancesVol. 9(16)
Novartis (Switzerland) (CH), The Royal Melbourne Hospital (AU), Memorial Sloan Kettering Cancer Center (US), The University of Texas MD Anderson Cancer Center (US), University of Mannheim (DE), Universidade de São Paulo (BR), Eulji University (KR), Heidelberg University (DE), Peter MacCallum Cancer Centre (AU), King Faisal Specialist Hospital & Research Centre (SA), University Hospital Heidelberg (DE), Princess Margaret Cancer Centre (CA), Federal Almazov North-West Medical Research Centre (RU), Ospedale Antonio Cardarelli (IT), Hemorio (BR), Instituto do Câncer do Estado de São Paulo (BR), Novartis (India) (IN), Hospital de Clínicas de Porto Alegre (BR), Assistance Publique – Hôpitaux de Paris (FR), Hospital Alemão Oswaldo Cruz (BR), National Medical Research Center for Hematology (RU), The Catholic University of Korea Uijeongbu St. Mary's Hospital (KR), Novartis (United States) (US), National Research Center for Hematology Russian Academy of Medical Sciences (RU), Russian Research Institute of Hematology and Transfusiology (RU), Jena University Hospital (DE), South Australian Health and Medical Research Institute (AU), National Cancer Center of Georgia (GE), Hôpital Saint-Louis (FR), National Cancer Center Hospital East (JP), Azienda di Rilievo Nazionale ed Alta Specializzazione (IT), Centre for Inflammation Research (GB), University Medical Centre Mannheim (DE), Hospital Universitario Ramón y Cajal (ES), Imperial College London (GB), Charité - Universitätsmedizin Berlin (DE)
Bristol-Myers Squibb, Pfizer, AstraZeneca, Sanofi, Incyte, National Institute for Health and Care Research, Astellas Pharma, Novartis Pharma
Good health and well-being
Openalex Percentile: Top 2%
Chronic Myeloid Leukemia Treatments
10.62
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