{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T12:18:06Z","timestamp":1791980286230,"version":"4.4.0"},"reference-count":36,"publisher":"American Society of Hematology","issue":"21","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2021,11,25]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Patients with chronic myeloid leukemia in chronic phase (CML-CP) resistant\/intolerant to \u22652 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 \u22652 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\u00a0= 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 \u22653 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 \u22652 prior TKIs. This trial was registered at www.clinicaltrials.gov as #NCT03106779.<\/jats:p>","DOI":"10.1182\/blood.2020009984","type":"journal-article","created":{"date-parts":[[2021,8,18]],"date-time":"2021-08-18T21:14:41Z","timestamp":1629321281000},"page":"2031-2041","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":307,"title":["A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs"],"prefix":"10.1182","volume":"138","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5379-7461","authenticated-orcid":false,"given":"Delphine","family":"R\u00e9a","sequence":"first","affiliation":[{"name":"DMU H\u00e9matologie, H\u00f4pital Saint-Louis, Paris, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2251-4032","authenticated-orcid":false,"given":"Michael J.","family":"Mauro","sequence":"additional","affiliation":[{"name":"Myeloproliferative Neoplasms Program, Memorial Sloan Kettering Cancer Center, New York, NY;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carla","family":"Boquimpani","sequence":"additional","affiliation":[{"name":"HEMORIO, State Institute of Hematology Arthur de Siquiera Cavalcanti, Rio de Janeiro, Brazil;"},{"name":"Oncocl\u00ednica Centro de Tratamento Oncol\u00f3gico, Rio de Janeiro, Brazil;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yosuke","family":"Minami","sequence":"additional","affiliation":[{"name":"Department of Hematology, National Cancer Center Hospital East, Kashiwa, Japan;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3290-7961","authenticated-orcid":false,"given":"Elza","family":"Lomaia","sequence":"additional","affiliation":[{"name":"Institute of Oncology and Hematology, Almazov National Medical Research Centre, St Petersburg, Russia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1784-0375","authenticated-orcid":false,"given":"Sergey","family":"Voloshin","sequence":"additional","affiliation":[{"name":"Hematology and Bone Marrow Transplantation, Russian Research Institute of Hematology and Transfusiology, St Petersburg, Russia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Turkina","sequence":"additional","affiliation":[{"name":"Scientific and Advisory Department of Hemotherapy of Myeloproliferative Disorders, National Research Center for Hematology, Moscow, Russia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dong-Wook","family":"Kim","sequence":"additional","affiliation":[{"name":"Hematologic Tumor Medicine Department, Uijeongbu Eulji Medical Center, Eulji University, Uijeongbu, South Korea;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1710-1794","authenticated-orcid":false,"given":"Jane F.","family":"Apperley","sequence":"additional","affiliation":[{"name":"Department of Immunology and Inflammation, Centre for Haematology Imperial College London, London, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7486-3525","authenticated-orcid":false,"given":"Andre","family":"Abdo","sequence":"additional","affiliation":[{"name":"Hemato-Oncology Department, Instituto do C\u00e2ncer do Estado de S\u00e3o Paulo (ICESPSP), S\u00e3o Paulo, Brazil;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura Maria","family":"Fogliatto","sequence":"additional","affiliation":[{"name":"Hematology and Hemotherapy Department, Hospital de Cl\u00ednicas de Porto Alegre (HCPA), Porto Alegre, Brazil;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis Dong Hwan","family":"Kim","sequence":"additional","affiliation":[{"name":"Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, Canada;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philipp","family":"le Coutre","sequence":"additional","affiliation":[{"name":"Department of Oncology and Hematology, Charit\u00e9\u2013Universit\u00e4tsmedizin Berlin, Berlin, Germany;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0357-5785","authenticated-orcid":false,"given":"Susanne","family":"Saussele","sequence":"additional","affiliation":[{"name":"Department of Haematology and Oncology, III. 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