Volume 8 Supplement 1

15th International Conference on Human Retroviruses: HTLV and Related Viruses

Open Access

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

  • Atae Utsunomiya1Email author,
  • Kensei Tobinai2,
  • Kazuhito Yamamoto3,
  • Takashi Ishida4,
  • Naokuni Uike5,
  • Kunihiro Tsukasaki6,
  • Kimiharu Uozumi7,
  • Masao Tomonaga8 and
  • Ryuzo Ueda4
Retrovirology20118(Suppl 1):A40

DOI: 10.1186/1742-4690-8-S1-A40

Published: 6 June 2011

Background

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.

Results

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.

Authors’ Affiliations

(1)
Hematology, Imamura Bun-in Hospital, Kagoshima
(2)
Hematology and Stem Cell Transplantation, National Cancer Center Hospital
(3)
Hematology and Cell Therapy, Aichi Cancer Center
(4)
Medical Oncology and Immunology, Nagoya City University
(5)
Hematology, National Kyushu Cancer Center
(6)
Hematology and Molecular Medicine, Nagasaki University
(7)
Hematology and Immunology, Kagoshima University, Kagoshima
(8)
Internal Medicine, Japanese Red Cross Nagasaki Genbaku Hospital

Copyright

© Utsunomiya et al; licensee BioMed Central Ltd. 2011

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 (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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