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Eur J Haematol. 2019 Feb 10. doi: 10.1111/ejh.13220. [Epub ahead of print]

Safety and effectiveness of mogamulizumab in relapsed or refractory adult T-cell leukemia-lymphoma.

Author information

1
Division of Hematology and Immunology, Center for Chronic Viral Diseases, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.
2
Medical Affairs, Kyowa Hakko Kirin Co., Ltd., Tokyo, Japan.
3
Pharmacovigilance and Quality Assurance Division, Kyowa Hakko Kirin Co., Ltd., Tokyo, Japan.
4
Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.

Abstract

OBJECTIVE:

This prospective, observational, postmarketing surveillance was conducted to evaluate the safety and effectiveness of mogamulizumab, an anti-CC chemokine receptor 4 (CCR4) monoclonal antibody, in patients with CCR4-positive, relapsed or refractory (r/r) adult T-cell leukemia-lymphoma (ATL) in Japan.

METHOD:

All patients were scheduled to receive intravenous infusions of mogamulizumab 1.0 mg/kg once weekly for 8 weeks, alone or in combination with other modalities.

RESULTS:

In the safety analysis population comprising 572 patients, mogamulizumab therapy was started between May 29, 2012, and April 30, 2013, and adverse drug reactions (ADRs) were reported in 73.4% (38.6% serious cases) of patients. The most common ADRs were skin disorders (33.2% [10.8% serious cases]), infusion-related reactions (30.1% [4.7% serious cases]), and infections (22.0% [14.7% serious cases]). In the effectiveness analysis population comprising 523 patients, the best overall response rate and the response rate at the end of therapy were 57.9% and 42.0%, respectively. The median overall survival was 5.5 months. Safety and effectiveness results were similar between patients aged ≥70 and <70 years.

CONCLUSION:

This postmarketing surveillance confirmed the safety and effectiveness of mogamulizumab for the treatment of patients with r/r ATL, including elderly patients, in clinical practice.

KEYWORDS:

ATL; elderly patients; mogamulizumab; postmarketing surveillance; relapsed or refractory

PMID:
30740787
DOI:
10.1111/ejh.13220

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