Venetoclax was approved in Japan for the treatment of AML in combination with azacitidine or low‐dose cytarabine in 2021 during the conduct of this study. Less intensive treatment or clinical trials are recommended in front‐line setting for elderly and unfit patients by the JSH guideline. Intensive treatment including allogenic stem cell transplantation is recommended for fit patients (young and no severe comorbidities) with AML. According to a survey conducted by the Ministry of Health, Labour and Welfare in 2017, AML is the most common acute leukemia and the number of patients in Japan with AML is approximately 7000. The combination of cusatuzumab and azacitidine is generally well tolerated in Japanese participants, and further exploration of this combination is warranted.Īcute myeloid leukemia (AML) is a heterogeneous disease characterized by uncontrolled clonal expansion of hematopoietic progenitor cells. No dose‐limiting toxicity was observed during the study period. All six participants had at least one treatment‐emergent adverse event, and the most common treatment‐emergent adverse events (all grades) were leukopenia (four participants ) and constipation (three participants ). Subsequently, cusatuzumab was administered intravenously on days 3 and 17 at 20 mg/kg in combination with azacitidine (75 mg/m 2) on days 1‐7 of each 28‐day cycle. Only in cycle 1, participants received cusatuzumab monotherapy on day 14. In this multicenter, single‐arm study, six participants were enrolled and treated. We present the results of a phase 1 study that evaluated the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary disease response to cusatuzumab, a novel anti‐CD70 monoclonal antibody, in combination with azacitidine, in newly diagnosed acute myeloid leukemia Japanese participants who were not candidates for intensive treatment.
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