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

• Published in: International journal of hematology 2017-10, Vol.106 (4), p.522-532
• Main Authors: Ishitsuka, Kenji, Yurimoto, Satoshi, Kawamura, Kouichi, Tsuji, Yukie, Iwabuchi, Manabu, Takahashi, Takeshi, Tobinai, Kensei
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Female; Graft-versus-host reaction; Hematology; Humans; Immunotherapy; Intravenous administration; Japan - epidemiology; Leukemia; Leukemia-Lymphoma, Adult T-Cell - drug therapy; Leukemia-Lymphoma, Adult T-Cell - epidemiology; Lymphocytes T; Lymphoma; Lysis; Male; Medicine; Medicine & Public Health; Middle Aged; Monoclonal antibodies; Oncology; Original Article; Patients; Product Surveillance, Postmarketing; Safety; Side effects; Skin; Stem cell transplantation; Surveillance; Targeted cancer therapy; Transplantation
• ISSN: 0925-5710; 1865-3774
• DOI: 10.1007/s12185-017-2270-9

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.