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Promising results of an anti-CCR4 antibody, KW-0761, for relapsed Adult T-Cell Leukemia-Lymphoma (ATL)


ATL is an aggressive T-cell malignancy caused by the virus HTLV-1 with a very poor outcome. ATL, and is characterized by its cell surface expression of CC chemokine receptor 4 (CCR4), to which KW-0761, a defucosylated, humanized antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC), binds. In a phase I study of KW-0761 in 13 patients (pts) with CCR4-positive relapsed ATL, encouraging efficacy of KW-0761 was observed (ORR of 31%; 2CRs and 2PRs, ref. 3). Here, we report the result of a pivotal phase II study of KW-0761 in pts with CCR4-positive relapsed ATL.


A multicenter phase II study of KW-0761 has been conducted for pts with CCR4 positive, relapsed aggressive ATL with the primary endpoint being overall response rate (ORR). Pts were planned to receive intravenous infusions of KW-0761 at 1.0 mg/kg once a week for 8 weeks. Twenty-eight pts were enrolled, among whom, 27 had at least one infusion of KW-0761. Most frequent adverse events (AEs) were mild to moderate in severity. The most frequent drug-related AEs were lymphopenia, acute infusion reaction, fever, skin rash, chill, thrombocytopenia and neutropenia. Among the 26 pts evaluable for efficacy, the ORR was 50% with 8 CRs and 5 PRs with response rates in each affected lesion being 100% (13/13) for peripheral blood, 63% (5/8) for skin, and 25% (3/12) for lymph node disease, respectively. Updated data including progression-free survival and overall survival, will be presented at the meeting with additional results of prognosis in the phase I study.

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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.

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Utsunomiya, A., Tobinai, K., Yamamoto, K. et al. Promising results of an anti-CCR4 antibody, KW-0761, for relapsed Adult T-Cell Leukemia-Lymphoma (ATL). Retrovirology 8 (Suppl 1), A40 (2011).

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