Canadian real-world experience of asciminib treatment in heavily pre-treated chronic myeloid leukemia (CML) patients who failed multiple lines of tyrosine kinase inhibitor (TKI) therapy.
Asciminib
Chronic myeloid leukemia
Real-world evidence
Tyrosine kinase inhibitors
Journal
Leukemia research
ISSN: 1873-5835
Titre abrégé: Leuk Res
Pays: England
ID NLM: 7706787
Informations de publication
Date de publication:
10 2023
10 2023
Historique:
received:
22
06
2023
revised:
16
08
2023
accepted:
21
08
2023
medline:
2
10
2023
pubmed:
2
9
2023
entrez:
1
9
2023
Statut:
ppublish
Résumé
Asciminib is a novel drug specifically targeting ABL myristoyl pocket in the ABL1 protein. Forty one patients with chronic myeloid leukemia treated with asciminib from 2018 to 2022 were reviewed and analyzed for the efficacy and tolerability of asciminib using real-world experience data. The median age was 60 years (range 17-90) with a past history of a cardiovascular event in 21 patients (51%). Patients were pretreated with a median of 3 previous tyrosine kinase inhibitors (range 1-5). After a median of 12 months of asciminib (range 3-41), major molecular response (MMR) rate was 39% (n = 11/28) and 42% (n = 5/12) at 6 and 12 months, respectively. Molecular response with 2 log reduction (MR2) was noted in 54% (n = 15/28) and 50% (n = 6/12) at 6 and 12 months. The cumulative incidence of MMR and MR2 was 46.3% and 66% at 12 months. Five patients discontinued asciminib due to treatment failure (n = 3) or thrombocytopenia (n = 2). There were no cardiovascular events. Out of 7 patients treated with high dose asciminib for T315I mutation, 5 patients achieved MMR or deeper response. The event-free survival was 63% at 12 months. This study confirmed clinical efficacy and tolerability of asciminib with real-world experience.
Sections du résumé
BACKGROUND
Asciminib is a novel drug specifically targeting ABL myristoyl pocket in the ABL1 protein.
METHODS
Forty one patients with chronic myeloid leukemia treated with asciminib from 2018 to 2022 were reviewed and analyzed for the efficacy and tolerability of asciminib using real-world experience data.
RESULTS
The median age was 60 years (range 17-90) with a past history of a cardiovascular event in 21 patients (51%). Patients were pretreated with a median of 3 previous tyrosine kinase inhibitors (range 1-5). After a median of 12 months of asciminib (range 3-41), major molecular response (MMR) rate was 39% (n = 11/28) and 42% (n = 5/12) at 6 and 12 months, respectively. Molecular response with 2 log reduction (MR2) was noted in 54% (n = 15/28) and 50% (n = 6/12) at 6 and 12 months. The cumulative incidence of MMR and MR2 was 46.3% and 66% at 12 months. Five patients discontinued asciminib due to treatment failure (n = 3) or thrombocytopenia (n = 2). There were no cardiovascular events. Out of 7 patients treated with high dose asciminib for T315I mutation, 5 patients achieved MMR or deeper response. The event-free survival was 63% at 12 months.
CONCLUSION
This study confirmed clinical efficacy and tolerability of asciminib with real-world experience.
Identifiants
pubmed: 37657146
pii: S0145-2126(23)00639-2
doi: 10.1016/j.leukres.2023.107374
pii:
doi:
Substances chimiques
asciminib
0
Tyrosine Kinase Inhibitors
0
Protein Kinase Inhibitors
0
Fusion Proteins, bcr-abl
EC 2.7.10.2
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
107374Informations de copyright
Copyright © 2023 Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest FK provides consultancy for Novartis, SC provides consultancy and has honoraria for Novartis, Pfizer, BMS, Celgene, Incite. AX, NF and LB has honoraria from Novartis. BL provides consultancy, has honoraria and on the advisory board for Novartis, Pfizer, BMS, Abbvie, and AMGEN. RK is on the advisory boards of Sanofi, FORUS Therapeutics, Belgene, Pfizer and has honoraria from Janssen and BMS. SA gets research funding from Novartis and has consultancy/ honoraria from Genentech/Roche, Astra Zeneca, Novartis, BMS, Jazz, Gilead, Amgen, Beigene, Abbvie, Paladin. DK is a consultant, has received research funding, and honoraria from Pfizer, Sanofi, Paladin, and Novartis. The remaining authors have no conflict of interest.