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Mogamulizumab, an anti-CCR4 monoclonal antibody, is a potent therapeutic option for adult T-cell leukemia-lymphoma

Adult T-cell leukemia-lymphoma (ATL) is a rare and aggressive T-cell malignancy associated with human T-cell lymphotropic virus type 1 (HTLV-1). ATL remains an extremely difficult disease to treat, and therefore, the development of novel therapies is highly needed. Because CC chemokine receptor 4 (CCR4) is frequently over-expressed on ATL cells from patients (Clin Cancer Res. 2003;9:3625), mogamulizumab, a defucosylated humanized anti-CCR4 antibody, has been developed for the treatment of ATL in Japan. In a phase I study in patients with relapsed CCR4-positive T-cell malignancies, mogamulizumab was well tolerated up to 1 mg/kg and encouraging efficacy was observed (JCO 2010;28:1591). In a subsequent pivotal phase II study in CCR4-positive relapsed ATL patients, mogamulizumab exhibited an overall response rate (ORR) of 50% including 8 complete responses (CR) (JCO 2012;30:837), leading to its approval in Japan in 2012 for relapsed/refractory ATL. Furthermore, with the aim of establishing a new standard therapy for untreated ATL, we conducted a randomized phase II study of VCAP-AMP-VECP, a dose-intensified multi-agent chemotherapy, with or without mogamulizumab (arm-A or arm-B). The CR rate (primary endpoint) and ORR (secondary endpoint) were higher in arm-A than in arm-B (52% vs. 33% and 86% vs. 75%, respectively). Median progression-free survival was also longer in arm-A (259 days vs. 192 days). The most common treatment-related AEs were hematological toxicity in both arms. These results suggest that mogamulizumab could provide a new effective treatment option for both relapsed/refractory and untreated ATL.

Trial registration NCT01173887

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Correspondence to Atae Utsunomiya.

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This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.

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Utsunomiya, A. Mogamulizumab, an anti-CCR4 monoclonal antibody, is a potent therapeutic option for adult T-cell leukemia-lymphoma. Retrovirology 11 (Suppl 1), O3 (2014).

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