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The present final analysis of the phase 1, open-label, nonrandomized trial (NCT02081378) assessed the long-term safety, tolerability, and antileukemic activity of asciminib in 115 patients with chronic myeloid leukemia in chronic phase without the <jats:italic>BCR::ABL1<\/jats:italic>\n            <jats:sup>T315I<\/jats:sup> mutation who received asciminib 10\u2013200\u2009mg twice daily (BID) or 80\u2013200\u2009mg once daily (cutoff: March 14, 2023). Median exposure duration was 5.9 (range, 0\u20138.4) years; 60.9% of patients continued receiving asciminib through post-trial access. Grade \u22653 adverse events (AEs) occurred in 88 patients (76.5%). AEs led to treatment discontinuation, dose adjustment\/interruption, or additional therapy in 15 (13.0%), 74 (64.3%), and 106 (92.2%) patients, respectively. Most first-ever AEs, particularly hematologic AEs, presented within the first year and no new safety signals emerged. Of 56 patients who achieved major molecular response, 50 maintained the response by cutoff; the Kaplan-Meier-estimated probability of maintaining this response for \u2265432 weeks (\u2009\u2248\u20098.3 years) was 88% (95% confidence interval, 78.2\u201397.0%). The recommended dose for expansion was determined at 40\u2009mg BID. With up to 8.4 years of treatment, asciminib continued to demonstrate long-term safety and efficacy in this population.<\/jats:p>","DOI":"10.1038\/s41375-025-02578-7","type":"journal-article","created":{"date-parts":[[2025,4,9]],"date-time":"2025-04-09T12:52:56Z","timestamp":1744203176000},"page":"1114-1123","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Asciminib monotherapy in patients with chronic myeloid leukemia in chronic phase without BCR::ABL1T315I treated with at least 2 prior TKIs: Phase 1 final results"],"prefix":"10.1038","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0626-0834","authenticated-orcid":false,"given":"Andreas","family":"Hochhaus","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3967-4267","authenticated-orcid":false,"given":"Dong-Wook","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8636-1071","authenticated-orcid":false,"given":"Jorge E.","family":"Cortes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9140-0610","authenticated-orcid":false,"given":"Koji","family":"Sasaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2251-4032","authenticated-orcid":false,"given":"Michael J.","family":"Mauro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0910-3730","authenticated-orcid":false,"given":"Timothy P.","family":"Hughes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1163-6162","authenticated-orcid":false,"given":"Massimo","family":"Breccia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3361-3981","authenticated-orcid":false,"given":"Moshe","family":"Talpaz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hironobu","family":"Minami","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7069-0997","authenticated-orcid":false,"given":"Yeow Tee","family":"Goh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7865-2306","authenticated-orcid":false,"given":"Daniel J.","family":"DeAngelo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2890-029X","authenticated-orcid":false,"given":"Fabian","family":"Lang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oliver","family":"Ottmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3790-0478","authenticated-orcid":false,"given":"Michael C.","family":"Heinrich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valle","family":"Gomez Garcia de Soria","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philipp","family":"le Coutre","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gessami","family":"Sanchez-Olle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3338-304X","authenticated-orcid":false,"given":"Meng","family":"Cao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie","family":"Pognan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shruti","family":"Kapoor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Hoch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Delphine","family":"Rea","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,4,9]]},"reference":[{"key":"2578_CR1","doi-asserted-by":"crossref","first-page":"966","DOI":"10.1038\/s41375-020-0776-2","volume":"34","author":"A Hochhaus","year":"2020","unstructured":"Hochhaus A, Baccarani M, Silver RT, Schiffer C, Apperley JF, Cervantes F, et al. 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D-WK: Novartis, Bristol Myers Squibb, Pfizer, II-Yand, and Takeda: grants. JEC: Novartis, Pfizer, and Bristol Myers Squibb: grants, consulting fees. KS: Novartis: research funding, honoraria. MJM: Bristol Myers Squibb, Takeda, and Pfizer: personal fees. TPH: Novartis, Bristol Myers Squibb, and Enliven: consultancy, research funding. MB: Bristol Myers Squibb, Celgene, Pfizer, Incyte, and Novartis: consultancy and honoraria; AbbVie: consultancy. MT: Imago: consultancy; Novartis and Takeda: research funding; Constellation Pharmaceuticals and Bristol Myers Squibb: membership on board of directors or advisory committees. HM: Bayer, Bristol Myers Squibb Japan, Celgene, Chugai Pharma, Daiichi Sankyo, Dainippon Sumitomo Pharma, Eisai, Kyowa Hakko Kirin, Lilly Japan, Novartis, Ono Pharmaceutical, Otsuka, Pfizer, Taiho Pharmaceutical, Takeda, MSD, and AbbVie: honoraria; Ono Pharmaceutical: consulting; Astellas Pharma, Chugai Pharma, Dainippon Sumitomo Pharma, Eisai, Kyowa Hakko Kirin, Lilly Japan, Ono Pharmaceutical, Taiho Pharmaceutical, Nippon Shinyaku, MSD, Boehringer Ingelheim, Daiichi Sankyo, Takeda, Nihonkayaku, Shionogi, Sanofi, Bayer Schering Pharma, Mitsubishi Tanabe Pharma, and Teijin Pharma: research funding. YTG: Pfizer, Johnson & Johnson, Amgen, MSD Pharma, Novartis, EUSA Pharma, Roche, Bristol Myers Squibb, and AbbVie: honoraria. DJD: AbbVie, Novartis, Blueprint, and GlycoMimetics: grants; AbbVie, Novartis, Blueprint, and GlycoMimetics: research funding; Amgen, Autolus, Blueprint, Forty-Seven, GlycoMimetics, Gilead, Incyte, Jazz, Kite, Novartis, Pfizer, Servier, and Takeda; consulting. AbbVie, Amgen, Autolus, Blueprint, Daiichi Sankyo, Forty-Seven, GlycoMimetics, Incyte, Jazz, Kite, Novartis, Pfizer, Servier, and Takeda: personal fees. FL: Bristol Myers Squibb, Incyte, and Celgene: consultancy, honoraria; Novartis: consultancy, honoraria, and research funding. OO: Incyte and Amgen: honoraria. MCH: Jonathan David Foundation (VA Merit Review grant [I01BX005358] and NCI R21 grant [R21CA263400]): partial salary support; Novartis, Deciphera, New Bay Pharmaceuticals, Cogent, IDRX, Theseus Pharmaceuticals: consulting; von Pfeffel Pharmaceuticals: SAB; Novartis: patents\/royalties\/other intellectual property licensed to Novartis (institutional license; treatment of GIST). VGGdS: Novartis, Pfizer, Bristol Myers Squibb, and Incyte: grants, nonfinancial support, and honoraria. PlC: Pfizer, Novartis, and Incyte: honoraria. GSO, MC, NP, SK, and MH are employees of Novartis. DR: Novartis, Pfizer, and Incyte: personal fees.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}