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In the phase 3 COMMODORE (NCT03182244) trial, patients with relapsed\/refractory\n                    <jats:italic>FLT3<\/jats:italic>\n                    -mutated AML from China, Russia, Singapore, Thailand, and Malaysia were randomized to gilteritinib (120\u00a0mg\/day) or SC. The long-term follow-up included assessments every 3 months for a maximum of 3 years from the end-of-treatment visit. The primary endpoint was overall survival (OS). Secondary endpoints included event-free survival (EFS), complete remission (CR) rate, hematopoietic stem cell transplantation (HSCT) rate, and transfusion maintenance and conversion rates. Overall, 276 patients (gilteritinib,\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009137; SC,\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009139) completed the long-term follow-up. Most (88.0%) patients were Asian. The median (95% confidence interval [CI]) OS was longer with gilteritinib versus SC (10.3 [8.8, 12.7] vs 5.4 [4.1, 8.1] months, respectively; hazard ratio [HR; 95% CI], 0.612 [0.451, 0.832]), with a median follow-up of 34.6 months. The median (95% CI) EFS was longer with gilteritinib versus SC (2.1 [&lt;\u20090.1, 3.2] vs 0.6 [0.2, 1.2] months, respectively; HR [95% CI], 0.589 [0.438, 0.792]). The CR rate was 20.4% and 11.5% in the gilteritinib and SC arms, respectively. During the entire study period, 22.6% and 7.9% of patients in the gilteritinib and SC arms underwent HSCT, respectively; 18.2% of patients in the gilteritinib arm received on-study HSCT. No new safety concerns were identified. Long-term gilteritinib treatment improved clinical outcomes compared with SC and was well-tolerated in a predominantly Asian population with relapsed\/refractory\n                    <jats:italic>FLT3<\/jats:italic>\n                    -mutated AML.\n                  <\/jats:p>","DOI":"10.1007\/s00277-026-06762-2","type":"journal-article","created":{"date-parts":[[2026,1,11]],"date-time":"2026-01-11T23:28:08Z","timestamp":1768174088000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Long-term follow-up of predominantly Asian patients with relapsed\/refractory FLT3-mutated acute myeloid leukemia in the phase 3 COMMODORE trial"],"prefix":"10.1007","volume":"105","author":[{"given":"Bin","family":"Jiang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jian","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ligen","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin","family":"Du","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1182-8132","authenticated-orcid":false,"given":"Hao","family":"Jiang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianda","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoxi","family":"Zeng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9585-3855","authenticated-orcid":false,"given":"Taishi","family":"Sakatani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4981-9450","authenticated-orcid":false,"given":"Masanori","family":"Kosako","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaru","family":"Deng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1536-9313","authenticated-orcid":false,"given":"Vladimir","family":"Ivanov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2446-8092","authenticated-orcid":false,"given":"Sergey","family":"Bondarenko","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lily Wong","family":"Lee Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Archrob","family":"Khuhapinant","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Martynova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nahla","family":"Hasabou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jamie Jung-Hee","family":"An","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9437-9151","authenticated-orcid":false,"given":"Jianxiang","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,1,12]]},"reference":[{"issue":"12","key":"6762_CR1","doi-asserted-by":"publisher","first-page":"1345","DOI":"10.1182\/blood.2022016867","volume":"140","author":"H D\u00f6hner","year":"2022","unstructured":"D\u00f6hner H, Wei AH, Appelbaum FR, Craddock C, DiNardo CD, Dombret H, Ebert BL, Fenaux P, Godley LA, Hasserjian RP, Larson RA, Levine RL, Miyazaki Y, Niederwieser D, Ossenkoppele G, R\u00f6llig C, Sierra J, Stein EM, Tallman MS, Tien HF, Wang J, Wierzbowska A, L\u00f6wenberg B (2022) Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN. 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TS reports Astellas stocks. VI reports consulting and honoraria fees for speakers\u2019 bureaus or educational events from AbbVie, Pfizer, Novartis, Sotex, Biocad, and AlPharma. AK reports consulting and honoraria fees from Roche, Johnson & Johnson, Novartis, American Taiwan Biopharm, AstraZeneca, Dr. Reddy\u2019s, Bristol Myers Squibb, and Apexcella; and support for attending meetings and\/or travel from American Taiwan Biopharm. XZ, TS, YD, JJHA, and NH are all employees of Astellas. MK was an employee of Astellas at the time the research was conducted. JW reports participation on an advisory board for AbbVie.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"The primary analysis of this study has been previously published (https:\/\/doi.org\/10.1038\/s41375-024-02382-9). These results have been presented in part as an oral presentation at the European Hematology Association Congress from June 12-15, 2025, in Milan, Italy.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Prior presentation"}}],"article-number":"3"}}