{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T22:23:20Z","timestamp":1788819800409,"version":"build-2803163510"},"reference-count":33,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,9,27]],"date-time":"2022-09-27T00:00:00Z","timestamp":1664236800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2023,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Asciminib, a first\u2010in\u2010class, allosteric inhibitor of BCR\u2010ABL1 that acts by STAMP (Specifically Targeting the ABL Myristoyl Pocket), is a novel therapeutic option for patients with chronic myeloid leukemia (CML). In the global, phase 3, open\u2010label ASCEMBL study in patients with CML in chronic phase (CML\u2010CP) pretreated with \u22652 tyrosine kinase inhibitors (TKIs) (NCT03106779), asciminib (40\u2009mg twice\u2010daily) demonstrated significant superiority over the ATP\u2010competitive TKI bosutinib (500\u2009mg once daily) for the primary endpoint of major molecular response (MMR; <jats:italic>BCR::ABL1<\/jats:italic> transcript levels on the international scale [<jats:italic>BCR::ABL1<\/jats:italic><jats:sup>IS<\/jats:sup>] \u22640.1%) at week 24. Here, we report results from a descriptive subgroup analysis of Japanese patients enrolled in ASCEMBL study (data cut\u2010off: May 25, 2020). Overall, 16 Japanese patients were randomized (asciminib, <jats:italic>n<\/jats:italic>\u00a0=\u00a013; bosutinib, <jats:italic>n<\/jats:italic>\u00a0=\u00a03). At week 24, the MMR rate with asciminib was 30.8% (4\/13; 95% confidence interval [CI], 9.09\u201361.43). <jats:italic>BCR::ABL1<\/jats:italic><jats:sup>IS<\/jats:sup> \u22641% and complete cytogenic response (CCyR) at week 24 were 61.5% (8\/13 patients) and 50.0% (4\/8 patients), respectively. In the bosutinib group, no patient achieved MMR, CCyR, or <jats:italic>BCR::ABL1<\/jats:italic><jats:sup>IS<\/jats:sup> \u22641%, but results were limited by the low number of patients. The safety profile of asciminib was comparable to that previously observed in the overall study population. Findings from this Japanese subgroup analysis of the ASCEMBL study support the use of asciminib for the treatment of Japanese patients with CML\u2010CP previously treated with \u22652 TKIs. ClinicalTrials.gov Identifier: NCT03106779.<\/jats:p>","DOI":"10.1002\/cam4.5212","type":"journal-article","created":{"date-parts":[[2022,9,28]],"date-time":"2022-09-28T04:42:31Z","timestamp":1664340151000},"page":"2990-2998","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Asciminib vs bosutinib in CML patients pretreated with \u22652 tyrosine kinase inhibitors: Results from the Japanese subgroup analysis of ASCEMBL study"],"prefix":"10.1002","volume":"12","author":[{"given":"Junichiro","family":"Yuda","sequence":"first","affiliation":[{"name":"National Cancer Center Hospital East  Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriko","family":"Doki","sequence":"additional","affiliation":[{"name":"Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Matsuoka","sequence":"additional","affiliation":[{"name":"Kobe University Hospital  Kobe Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takafumi","family":"Yokota","sequence":"additional","affiliation":[{"name":"Osaka University Hospital  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihiro","family":"Tomita","sequence":"additional","affiliation":[{"name":"Fujita Health University School of Medicine  Toyoake Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoto","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Akita University Hospital  Akita Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Itaru","family":"Matsumura","sequence":"additional","affiliation":[{"name":"Kindai University Hospital  Osaka 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Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Allepuz","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yosuke","family":"Minami","sequence":"additional","affiliation":[{"name":"National Cancer Center Hospital East  Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,9,27]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199907153410306"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40880-016-0108-0"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2013-05-501569"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2020.0047"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx219"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185-020-02964-0"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.66.2866"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13045-021-01055-9"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185-020-02843-8"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.leukres.2013.09.011"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185-019-02613-1"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185-017-2208-2"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185-017-2353-7"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185-017-2239-8"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185-017-2238-9"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1177\/1947601912458584"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clml.2015.03.006"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.leukres.2020.106458"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.8b01040"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1038\/nature21702"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccell.2019.08.004"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1902328"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2020-139677"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2020009984"},{"key":"e_1_2_11_26_1","doi-asserted-by":"crossref","unstructured":"MauroMJ MinamiY ReaD et al.Efficacy and safety results from Ascembl a multicenter open\u2010label phase 3 study of asciminib a rirst\u2010in\u2010class STAMP inhibitor vs bosutinib in patients with chronic myeloid leukemia in chronic phase after \u22652 prior tyrosine kinase inhibitors: update after 48\u2009weeks. Presented at ASH 2021; December 11\u201314 2021. Abstract 310.","DOI":"10.1182\/blood-2021-152561"},{"key":"e_1_2_11_27_1","unstructured":"U. S. Food and Drug Administration.FDA approves asciminib for Philadelphia chromosome\u2010positive chronic myeloid leukemia. (Accessed November 2021).https:\/\/www.fda.gov\/drugs\/resources\u2010information\u2010approved\u2010drugs\/fda\u2010approves\u2010asciminib\u2010philadelphia\u2010chromosome\u2010positive\u2010chronic\u2010myeloid\u2010leukemia."},{"key":"e_1_2_11_28_1","unstructured":"Pharmaceuticals and Medical Devices Agency Japan. (Accessed March 2022).https:\/\/www.pmda.go.jp\/PmdaSearch\/iyakuDetail\/ResultDataSetPDF\/300242_42910F5F1024_1_01."},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41375-020-0776-2"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1158\/1535-7163.MCT-20-0069"},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.3109\/10428194.2012.695779"},{"key":"e_1_2_11_32_1","volume-title":"Bosulif (bosutinib) [package insert]","year":"2020"},{"key":"e_1_2_11_33_1","volume-title":"Bosulif (bosutinib) [Summary of Product Characteristics]","year":"2020"},{"key":"e_1_2_11_34_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185-022-03314-y"}],"container-title":["Cancer Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cam4.5212","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cam4.5212","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cam4.5212","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,25]],"date-time":"2024-11-25T08:26:37Z","timestamp":1732523197000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/cam4.5212"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9,27]]},"references-count":33,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2023,2]]}},"alternative-id":["10.1002\/cam4.5212"],"URL":"https:\/\/doi.org\/10.1002\/cam4.5212","archive":["Portico"],"relation":{},"ISSN":["2045-7634","2045-7634"],"issn-type":[{"value":"2045-7634","type":"print"},{"value":"2045-7634","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,9,27]]},"assertion":[{"value":"2022-03-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-08-24","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-09-27","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}