{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T19:19:37Z","timestamp":1787685577435,"version":"build-2784847793"},"reference-count":55,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T00:00:00Z","timestamp":1784160000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T00:00:00Z","timestamp":1784160000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Novartis Pharma AG"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Leukemia"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    In chronic myeloid leukemia in chronic phase (CML-CP),\n                    <jats:italic>BCR::ABL1<\/jats:italic>\n                    <jats:sup>T315I<\/jats:sup>\n                    commonly leads to treatment resistance, worse patient outcomes, and limited subsequent treatment options. By targeting the ABL1 myristoyl pocket, asciminib maintains activity against\n                    <jats:italic>BCR::ABL1<\/jats:italic>\n                    <jats:sup>T315I<\/jats:sup>\n                    . We report final long-term safety, tolerability, and efficacy results with asciminib in 48 patients with T315I-mutated CML-CP who received asciminib 200\u2009mg twice daily in the phase 1, nonrandomized trial (NCT02081378). After a median exposure of 3.5 years, 52.1% of patients continued to receive asciminib via posttrial access. Of 45 evaluable patients, 24 (53.3%) achieved major molecular response (MMR); 20 of 24 maintained or deepened their response by the cutoff. The Kaplan-Meier estimated proportion of patients maintaining their first MMR for at least 144 weeks (2.8 years) was 86% (95% CI: 71.9\u2013100.0%). The safety profile showed no new or worsening safety signals. With 1.4 years\u2019 additional exposure since the previous analysis, the incidence of grade \u22653 adverse events (AEs) (60.4%) did not increase. Four patients (8.3%) discontinued due to AEs. The exposure-adjusted incidence rate of first all-grade AOEs was 4.4 cases per 100 patient-years. With up to approximately 6 years of exposure, this final analysis confirms asciminib as a treatment option for patients with T315I-mutated CML-CP.\n                  <\/jats:p>","DOI":"10.1038\/s41375-026-02972-9","type":"journal-article","created":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T08:10:50Z","timestamp":1784189450000},"page":"1893-1900","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Asciminib monotherapy in patients with BCR::ABL1 T315I-mutated chronic-phase chronic myeloid leukemia: phase 1 trial final results"],"prefix":"10.1038","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8636-1071","authenticated-orcid":false,"given":"Jorge E.","family":"Cortes","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Delphine","family":"Rea","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\/0000-0003-0626-0834","authenticated-orcid":false,"given":"Andreas","family":"Hochhaus","sequence":"additional","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"}]},{"given":"Koji","family":"Sasaki","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"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3790-0478","authenticated-orcid":false,"given":"Michael C.","family":"Heinrich","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\/0000-0002-2987-1331","authenticated-orcid":false,"given":"Michael","family":"Deininger","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\/0000-0001-9567-1955","authenticated-orcid":false,"given":"Jeroen J. 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DR received personal fees from Novartis, Pfizer, and Incyte. MJM received personal fees from Bristol Myers Squibb, Takeda, and Pfizer. AH received research funding from Novartis, Bristol Myers Squibb, Pfizer, Enliven, Terns and Incyte. D-WK received research funding and honoraria for speakers bureaus from Novartis, Bristol Myers Squibb, Korea Otsuka, and ILYANG; research funding and honoraria from Enliven; and research funding from PharmaEssentia. KS received research funding and honoraria from Novartis. FL received consultancy and honoraria from Bristol Myers Squibb, Incyte, and Celgene and consultancy, honoraria, and research funding from Novartis. MCH held an equity interest in MolecularMD and holds multiple patents on the diagnosis and\/or treatment of gastrointestinal stromal tumors; one patent on treatment has been licensed by Oregon Health & Science University to Novartis. MB received consultancy and honoraria from Bristol Myers Squibb, Celgene, Pfizer, Incyte, and Novartis and consultancy from AbbVie. MD received consultancy from Fusion Pharma, Blueprint, Pfizer, Novartis, Medscape, and Sangamo; research funding from Pfizer; and has membership on the board of directors or advisory committees from Takeda, Sangamo, and Blueprint. Y-TG received consulting fees and honoraria from Novartis, AstraZeneca, Antengene, Amgen, EUSA Pharma, Pfizer, and Johnson & Johnson and honoraria from MSD, Roche, Astellas, and AbbVie. JJWMJ received research funding from Novartis and Bristol Myers Squibb; speaker\u2019s fee from Incyte; honoraria from AbbVie, Novartis, Pfizer, and Incyte; and support for the nonprofit Apps for Care and Science Foundation (of which JJWMJ is president) from AbbVie, Alexion, Amgen, Astellas, Bristol Myers Squibb, Daiichi Sankyo, Janssen-Cilag, Olympus, Incyte, Sanofi Genzyme, Servier, Jazz, and Takeda. MT received consultancy from IMAGO, research funding from Novartis and Takeda, and membership on the board of directors or advisory committees from Constellation Pharmaceuticals and Bristol Myers Squibb. MVG received grants, nonfinancial support, and honoraria from Novartis, Pfizer, Bristol Myers Squibb, and Incyte. PlC received honoraria from Novartis, Incyte, Blueprint, Pfizer, Bristol Myers Squibb, and AOP. F-XM received grants, honoraria, consultancy, and research funding from Novartis and honoraria from Bristol Myers Squibb and Pfizer. DD received grants from AbbVie, Novartis, Blueprint, and GlycoMimetics; research funding from AbbVie, Novartis, Blueprint, and GlycoMimetics; consulting from AbbVie, Amgen, Autolus, Blueprint, Forty-Seven, GlycoMimetics, Incyte, Jazz, Kite, Novartis, Pfizer, Servier, and Takeda; and personal fees from AbbVie, Amgen, Autolus, Blueprint, Forty-Seven, GlycoMimetics, Incyte, Jazz, Kite, Novartis, Pfizer, Servier, and Takeda. AD, SK, GSO, MH, NA and SQ are employees of Novartis. TPH received research funding and honoraria for advisory boards from Novartis and honoraria for advisory boards from Takeda, Enliven, and Terns.","order":1,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Ethics"}}]}}