International Journal of Hematology

DOI: 10.1007/s12185-017-2270-9 Pages: 522-532

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

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

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

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

4. National Cancer Center Hospital, Department of Hematology

Correspondence to:
Kenji Ishitsuka
Tel: +81 99 275 5934



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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