Safety and effectiveness of mogamulizumab in relapsed or refractory CC chemokine receptor 4-positive peripheral T-cell lymphoma and relapsed or refractory cutaneous T-cell lymphoma: A post-marketing surveillance in Japan

IF 3.3 4区 医学 Q2 HEMATOLOGY Hematological Oncology Pub Date : 2024-06-07 DOI:10.1002/hon.3292
Kenji Ishitsuka, Tomoharu Yasukawa, Yukie Tsuji
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Abstract

Mogamulizumab is a humanized antibody targeting CC chemokine receptor 4 (CCR4). This post-marketing surveillance was conducted in Japan as a regulatory requirement from 2014 to 2020 to ensure the safety and effectiveness of mogamulizumab in patients with relapsed or refractory (r/r) CCR4-positive peripheral T-cell lymphoma (PTCL) or r/r cutaneous T-cell lymphoma (CTCL). Safety and effectiveness data were collected for up to 31 weeks after treatment initiation. A total of 142 patients were registered; safety was evaluated in 136 patients. The median number of doses was 8.0 (range, 1–18). The main reasons for treatment termination were insufficient response (22.1%) and adverse events (13.2%). The frequency of any grade adverse drug reaction was 57.4%, including skin disorders (26.5%), infections and immune system disorders (16.2%), and infusion-related reactions (13.2%). Graft-versus-host disease, grade 2, developed in one of two patients who underwent allogeneic-hematopoietic stem cell transplantation after receiving mogamulizumab. Effectiveness was evaluated in 131 patients (103 with PTCL; 28 with CTCL). The best overall response rate was 45.8% (PTCL, 47.6%; CTCL, 39.3%). At week 31, the survival rate was 69.0% (95% confidence interval, 59.8%–76.5%) [PTCL, 64.4% (54.0%–73.0%); CTCL, 90.5% (67.0%–97.5%)]. Safety and effectiveness were comparable between patients <70 and ≥ 70 years old and between those with relapsed and refractory disease. The safety and effectiveness of mogamulizumab for PTCL and CTCL in the real world were comparable with the data reported in previous clinical trials.

Clinical Trial Registration

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mogamulizumab治疗复发或难治性CC趋化因子受体4阳性外周T细胞淋巴瘤和复发或难治性皮肤T细胞淋巴瘤的安全性和有效性:日本上市后监测。
Mogamulizumab 是一种靶向 CC 趋化因子受体 4 (CCR4) 的人源化抗体。作为一项监管要求,日本从2014年至2020年开展了这项上市后监测,以确保莫加单抗在复发或难治性(r/r)CCR4阳性外周T细胞淋巴瘤(PTCL)或r/r皮肤T细胞淋巴瘤(CTCL)患者中的安全性和有效性。在开始治疗后收集了长达 31 周的安全性和有效性数据。共登记了 142 例患者;对 136 例患者进行了安全性评估。治疗剂量的中位数为 8.0 次(1-18 次)。终止治疗的主要原因是反应不足(22.1%)和不良反应(13.2%)。任何级别的药物不良反应发生率为57.4%,包括皮肤病(26.5%)、感染和免疫系统紊乱(16.2%)以及输液相关反应(13.2%)。在接受莫干单抗治疗后进行异基因造血干细胞移植的两名患者中,有一人出现了2级移植物抗宿主病。对131名患者(103名PTCL患者;28名CTCL患者)进行了疗效评估。最佳总体反应率为45.8%(PTCL,47.6%;CTCL,39.3%)。第31周时,存活率为69.0%(95%置信区间,59.8%-76.5%)[PTCL,64.4%(54.0%-73.0%);CTCL,90.5%(67.0%-97.5%)]。患者的安全性和有效性相当
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来源期刊
Hematological Oncology
Hematological Oncology 医学-血液学
CiteScore
4.20
自引率
6.10%
发文量
147
审稿时长
>12 weeks
期刊介绍: Hematological Oncology considers for publication articles dealing with experimental and clinical aspects of neoplastic diseases of the hemopoietic and lymphoid systems and relevant related matters. Translational studies applying basic science to clinical issues are particularly welcomed. Manuscripts dealing with the following areas are encouraged: -Clinical practice and management of hematological neoplasia, including: acute and chronic leukemias, malignant lymphomas, myeloproliferative disorders -Diagnostic investigations, including imaging and laboratory assays -Epidemiology, pathology and pathobiology of hematological neoplasia of hematological diseases -Therapeutic issues including Phase 1, 2 or 3 trials as well as allogeneic and autologous stem cell transplantation studies -Aspects of the cell biology, molecular biology, molecular genetics and cytogenetics of normal or diseased hematopoeisis and lymphopoiesis, including stem cells and cytokines and other regulatory systems. Concise, topical review material is welcomed, especially if it makes new concepts and ideas accessible to a wider community. Proposals for review material may be discussed with the Editor-in-Chief. Collections of case material and case reports will be considered only if they have broader scientific or clinical relevance.
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