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Safety and efficacy of mogamulizumab in patients with adult T-cell leukemia–lymphoma in Japan: interim results of postmarketing all-case surveillance

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Abstract

We present the interim results of a postmarketing all-case surveillance study in patients with C–C chemokine receptor 4 (CCR4)-positive, relapsed or refractory adult T-cell leukemia–lymphoma (ATL) treated with the anti-CCR4 monoclonal antibody mogamulizumab since its 2012 launch in Japan. The safety and efficacy analysis populations comprised 484 and 442 patients, respectively. The ATL subtype was acute in 58.9% and lymphoma in 34.2% of patients. All patients were scheduled to receive intravenous infusions of mogamulizumab (1.0 mg/kg) once weekly for eight weeks, alone or in combination with other modalities. Adverse drug reactions (ADRs) were reported in 74.0% of patients, of which 35.7% were serious and 6.2% were fatal. The priority survey items of infusion-related reaction, skin disorder, infection, immune disorder, and tumor lysis syndrome were reported in 29.3, 34.3, 22.1, 3.5, and 2.5% of patients, respectively. Graft-versus-host disease was reported in 25/42 patients who received mogamulizumab before allogeneic hematopoietic stem cell transplantation. The best overall response rate was 57.7% overall, 57.5% in patients treated with mogamulizumab alone, and 58.2% in patients treated with combination therapy. This surveillance indicates that mogamulizumab shows acceptable tolerability in practice; however, because of the risk of serious/fatal ADRs, patients administered mogamulizumab should be carefully monitored.

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Acknowledgements

The authors wish to thank Denise Daley, MD, and Marion Barnett of Edanz Group Japan K.K. for providing medical writing support during the development of this manuscript, which was funded by Kyowa Hakko Kirin Co., Ltd.

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Authors and Affiliations

  1. Division of Hematology and Immunology, Center for Chronic Viral Diseases, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan

    Kenji Ishitsuka

  2. Medical Affairs, Kyowa Hakko Kirin Co., Ltd., Tokyo, Japan

    Satoshi Yurimoto, Kouichi Kawamura & Takeshi Takahashi

  3. Pharmacovigilance and Quality Assurance Division, Kyowa Hakko Kirin Co., Ltd., Tokyo, Japan

    Yukie Tsuji & Manabu Iwabuchi

  4. Department of Hematology, National Cancer Center Hospital, Tokyo, Japan

    Kensei Tobinai

Authors
  1. Kenji Ishitsuka
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  2. Satoshi Yurimoto
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  4. Yukie Tsuji
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  5. Manabu Iwabuchi
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  6. Takeshi Takahashi
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  7. Kensei Tobinai
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Correspondence to Kenji Ishitsuka.

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Conflict of interest

KI reports grants and personal fees from Kyowa Hakko Kirin, Chugai Pharmaceutical, Takeda Pharmaceutical, Novartis, Eisai, and Taiho Pharmaceutical; personal fees from Bristol-Myers Squibb, Celgene, Janssen Pharmaceutical, and Pfizer; and grants from Yakult Pharmaceutical, MSD, and Japan Blood Products Organization, outside the submitted work. SY, KK, and YT are employees and stockholders of Kyowa Hakko Kirin. MI and TT are employees of Kyowa Hakko Kirin. KT reports grants and personal fees from Eisai, Takeda, Janssen, and Mundipharma; personal fees from Zenyaku Kogyo, and HUYA Bioscience International; and grants from Chugai Pharma, Kyowa Hakko Kirin, Ono Pharmaceutical Celgene, GlaxoSmithKline, SERVIER, and Abbvie, outside the submitted work.

Funding

This study was funded by Kyowa Hakko Kirin Co., Ltd.

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Ishitsuka, K., Yurimoto, S., Kawamura, K. et al. Safety and efficacy of mogamulizumab in patients with adult T-cell leukemia–lymphoma in Japan: interim results of postmarketing all-case surveillance. Int J Hematol 106, 522–532 (2017). https://doi.org/10.1007/s12185-017-2270-9

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  • DOI: https://doi.org/10.1007/s12185-017-2270-9

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