Safety and effectiveness of mogamulizumab in relapsed or refractory adult T‐cell leukemia‐lymphoma. (12th March 2019)

• Record Type: Journal Article
• Authors: Ishitsuka, Kenji; Yurimoto, Satoshi; Tsuji, Yukie; Iwabuchi, Manabu; Takahashi, Takeshi; Tobinai, Kensei
• Is Part Of: European journal of haematology. Volume 102:Number 5(2019)
• Page Start: 407
• Page End: 415
• Publication Date: 2019-03-12
• Subjects: ATL -- elderly patients -- mogamulizumab -- postmarketing surveillance -- relapsed or refractory; Hematology -- Periodicals; Blood -- Diseases -- Periodicals; Blood -- Periodicals; 616.15005
• DOI: 10.1111/ejh.13220
• Languages: English
• ISSNs: 0902-4441

Abstract

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.