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We present final results of a phase-1 vamotinib dose-escalation study to identify maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) followed by expansion cohorts. 51 subjects with chronic myeloid leukaemia (CML) failing\u2009\u2265\u20091 2nd generation TKI or with\n                    <jats:italic>BCR::ABL1<\/jats:italic>\n                    <jats:sup>T315I<\/jats:sup>\n                    were enrolled. Subjects received vamotinib, 50\u2013750\u00a0mg\/d, continuously. Median exposure was 6 months (range, &lt;\u20091\u201352 months). Median CML duration pre-study was 10 years (range, &lt;\u20091\u201323 years). 27 subjects received\u2009\u2265\u20093 prior TKIs and 16 had\n                    <jats:italic>BCR::ABL1<\/jats:italic>\n                    <jats:sup>T315I<\/jats:sup>\n                    . The MTD was 600\u00a0mg with the Grade-3 psoriasis-like skin toxicity as the DLT. There were no vascular occlusive events nor deviations of ankle-brachial index. Complete haematologic response (CHR) was achieved in 14 of 30 subjects, major cytogenetic response (MCyR) in 14 of 44 subjects, complete cytogenetic response (CCyR) in 10 of 50 and major molecular response (MMR) in 7 of 51 subjects who did not have a CHR, MCyR, CCyR or MMR at enrollment. The best safety\/efficacy dose was 300\u00a0mg with MCyR achieved in 6 of 7 subjects, CCyR in 5 of 9 and MMR in 4 of 9 subjects who did not have a MCyR, CCyR or MMR at enrollment. 5 of 16 subjects with\n                    <jats:italic>BCR::ABL1<\/jats:italic>\n                    <jats:sup>T315I<\/jats:sup>\n                    responded including 3 achieving a CHR, 3, a MCyR, and 1,a CCyR. 2 of 5 subjects failing ponatinib achieved a CHR. Vamotinib dose for further phase-3 study is 300\u00a0mg\/d.\n                  <\/jats:p>","DOI":"10.1007\/s00277-025-06239-8","type":"journal-article","created":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T00:19:21Z","timestamp":1745885961000},"page":"2707-2715","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Phase-1 study of vamotinib (PF-114), a 3rd generation BCR::ABL1 tyrosine kinase-inhibitor, in chronic myeloid leukaemia"],"prefix":"10.1007","volume":"104","author":[{"given":"Anna","family":"Turkina","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Vinogradova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elza","family":"Lomaia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evgeniya","family":"Shatokhina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oleg","family":"Shukhov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ekaterina","family":"Chelysheva","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dzhariyat","family":"Shikhbabaeva","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irina","family":"Nemchenko","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Petrova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anastasiya","family":"Bykova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nadiya","family":"Siordiya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vasily","family":"Shuvaev","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilya","family":"Mikhailov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fedor","family":"Novikov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Veronika","family":"Shulgina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Hochhaus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oliver","family":"Ottmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorge","family":"Cortes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert Peter","family":"Gale","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ghermes","family":"Chilov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,4,29]]},"reference":[{"key":"6239_CR1","doi-asserted-by":"publisher","first-page":"2408","DOI":"10.1056\/NEJMoa062867","volume":"355","author":"BJ Druker","year":"2006","unstructured":"Druker BJ, Guilhot F, O\u2019Brien SG et al (2006) Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia. 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The study was conducted in accordance with the 1964 Declaration of Helsinki and the Good Clinical Practice Guidelines of the International Conference on Harmonization. All patients provided written informed consent.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"AT \u2013 speaker: Novartis, Pfizer, R-Pharm, consultancy\/advisory board: Novartis; OV: no competing interests to declare; EL has received fees for lecturing and expert opinion from Novartis, Pfizer, Sotex, Pharmstandard and Fusion Pharma; ES: no competing interests to declare; OS: no competing interests to declare; EC \u2013 speaker: Novartis, Pfizer, R-Pharm, consultancy: Ascentage Pharma; DS: no competing interests to declare; IN: no competing interests to declare; AP: speaker: Novartis, Alexpharm; AB: no competing interests to declare; NS: no competing interests to declare; Vasily Shuvaev received fees for lecturing and expert opinion from Novartis, Pfizer, Amgen, and AbbVie; IM: no competing interests to declare; FN was employed by Fusion Pharma; Veronika Shulgina: was employed by Fusion Pharma; AH: Honoraria and research funding (Novartis, Incyte); research funding (Bristol Myers Squibb, Pfizer, MSD); OO: Amgen, Incyte, Celgene, Roche, Fusion Pharma, Novartis: honoraria. Amgen, Incyte, and Celgene: research funding; JC: Consultancy (Pfizer, Takeda, Nerviano, Sun Pharma, Novartis, Biopath Holdings, Tigel); research funding (Ascentage, Novartis, Sun Pharma, Tern Pharma, Abbvie); membership on an entity\u2019s board of directors or advisory committees (BioPath Holdings); RPG is a consultant to Antengene Biotech LLC, Ascentage Pharma Group and NexImmune Inc.; Medical Director, FFF Enterprises Inc.; A speaker for Janssen Pharma and Hengrui Pharma; Board of Directors: Russian Foundation for Cancer Research Support; and Scientific Advisory Boards, Nanexa AB and StemRad Ltd.; GC is employed by Fusion Pharma.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}