A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs

博舒替尼 医学 中止 不利影响 内科学 尼罗替尼 肿瘤科 随机对照试验 伊马替尼 髓系白血病
作者
Delphine Réa,Michael J. Mauro,Carla Boquimpani,Yosuke Minami,Е Г Ломаиа,S. Voloshin,Anna Turkina,Dong-Wook Kim,Jane F. Apperley,André Abdo,Laura Fogliatto,Dennis Dong Hwan Kim,Philipp le Coutre,Susanne Saußele,Mario Annunziata,Timothy P. Hughes,Naeem Chaudhri,Koji Sasaki,Lynette Chee,Valentín García‐Gutiérrez,Jorge Cortes,Paola Aimone,Alejandro Allepuz,Sara Quenet,Véronique Bédoucha,Andreas Hochhaus
出处
期刊:Blood [American Society of Hematology]
卷期号:138 (21): 2031-2041 被引量:156
标识
DOI:10.1182/blood.2020009984
摘要

Abstract Patients with chronic myeloid leukemia in chronic phase (CML-CP) resistant/intolerant to ≥2 tyrosine kinase inhibitors (TKIs) are at high risk of experiencing poor outcomes because of disease biology and inadequate efficacy and/or safety of current therapies. Asciminib, a first-in-class BCR-ABL1 inhibitor Specifically Targeting the ABL Myristoyl Pocket (STAMP), has the potential to overcome resistance/intolerance to approved TKIs. In this phase 3, open-label study, patients with CML-CP previously treated with ≥2 TKIs were randomized (2:1) to receive asciminib 40 mg twice daily vs bosutinib 500 mg once daily. Randomization was stratified by major cytogenetic response (MCyR) status at baseline. The primary objective was to compare the major molecular response (MMR) rate at week 24 for asciminib vs bosutinib. A total of 233 patients were randomized to asciminib (n = 157) or bosutinib (n = 76). Median follow-up was 14.9 months. The MMR rate at week 24 was 25.5% with asciminib and 13.2% with bosutinib. The difference in MMR rate between treatment arms, after adjusting for MCyR at baseline, was 12.2% (95% confidence interval, 2.19-22.30; 2-sided P = .029). Fewer grade ≥3 adverse events (50.6% vs 60.5%) and adverse events leading to treatment discontinuation (5.8% vs 21.1%) occurred with asciminib than with bosutinib. The study showed a superior efficacy of asciminib compared with that of bosutinib, together with a favorable safety profile. These results support the use of asciminib as a new therapy in patients with CML-CP who are resistant/intolerant to ≥2 prior TKIs. This trial was registered at www.clinicaltrials.gov as #NCT03106779.
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