{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,10]],"date-time":"2026-11-10T16:36:15Z","timestamp":1794328575981,"version":"4.9.0"},"reference-count":27,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"31","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2025,11]]},"abstract":"\n PURPOSE<\/jats:title>\n \n Ziftomenib\u2014a potent, highly selective, oral menin inhibitor\u2014was well tolerated and demonstrated encouraging clinical activity as monotherapy for relapsed\/refractory\n NPM1<\/jats:italic>\n -mutated (\n NPM1<\/jats:italic>\n -m) and\n KMT2A<\/jats:italic>\n -rearranged AML in the KOMET-001 phase I trial.\n <\/jats:p>\n <\/jats:sec>\n \n METHODS<\/jats:title>\n \n In the registration-enabling phase II part of KOMET-001, patients with relapsed\/refractory\n NPM1<\/jats:italic>\n -m AML received ziftomenib 600 mg once daily. The primary end point was the rate of complete remission with full hematologic recovery (CR)\/CR with partial hematologic recovery (CRh).\n <\/jats:p>\n <\/jats:sec>\n \n RESULTS<\/jats:title>\n \n From January 26, 2023, to May 13, 2024, 92 patients (median age, 69 years [range, 33-84]) were treated. The primary end point was met, with a CR\/CRh rate of 22% (95% CI, 14 to 32;\n P<\/jats:italic>\n = .0058); 61% were negative for measurable residual disease. Overall response rate was 33% (95% CI, 23 to 43), with a median duration of 4.6 months (95% CI, 2.8 to 7.4). Prespecified subgroup analyses showed comparable CR\/CRh regardless of previous therapy, including venetoclax, or type of comutations. Median overall survival was 6.6 months (95% CI, 3.6 to 8.6). Common grade \u22653 treatment-emergent adverse events were febrile neutropenia (26%), anemia (20%), and thrombocytopenia (20%). Differentiation syndrome occurred in 25% of patients (15% grade 3; no grade 4-5) and was manageable with protocol-defined mitigation. Three patients (3%) discontinued treatment because of ziftomenib-related adverse events.\n <\/jats:p>\n <\/jats:sec>\n \n CONCLUSION<\/jats:title>\n \n Ziftomenib demonstrated significant clinical benefit and deep responses in patients with heavily pretreated, relapsed\/refractory\n NPM1<\/jats:italic>\n -m AML. 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