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真实世界中贝兰他单抗mafodotin 单药治疗三药难治性多发性骨髓瘤的疗效和安全性。

Real-World Effectiveness and Safety of Belantamab Mafodotin Monotherapy in Triple-Class Refractory Multiple Myeloma.

机构信息

Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, 157 72 Athens, Greece.

出版信息

Int J Mol Sci. 2023 Jul 23;24(14):11829. doi: 10.3390/ijms241411829.

Abstract

B-cell maturation antigen (BCMA) is a promising therapeutic target for multiple myeloma (MM). The aim of this study was to assess the effectiveness and tolerability of monotherapy with the conjugated anti-BCMA monoclonal antibody belantamab mafodotin in triple-class refractory patients with MM in real-world practice. Patients refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 monoclonal antibody received belantamab mafodotin at 2.5 mg/kg intravenously every 3 weeks. Overall, 27 patients with a median age of 65 years (range 41-81) were included. Of these, 52% were male and the median number of prior lines of treatment was 5 (4-10). The overall response rate (partial response or better) was 52%, whereas the disease control rate (stable disease or better) was 70%. The median progression-free survival (PFS) was 2 months (95%CI: 0-7), whereas the median PFS among the responders was 12 months (95%CI: 6-18). Regarding the toxicity profile, the most common toxicity was eye toxicity, in 44% of the patients. Keratopathy grade 2-3 was reported in 33.3% of the patients. In conclusion, belantamab mafodotin showed a safety and efficacy profile consistent with the results of the registrational study. Importantly, heavily pretreated patients who responded to treatment derived a substantial survival benefit.

摘要

B 细胞成熟抗原 (BCMA) 是多发性骨髓瘤 (MM) 的一种有前途的治疗靶点。本研究旨在评估在真实世界实践中,三药难治性多发性骨髓瘤患者接受单药联合抗 BCMA 单克隆抗体 belantamab mafodotin 治疗的有效性和耐受性。至少对一种蛋白酶体抑制剂、一种免疫调节剂和一种抗 CD38 单克隆抗体耐药的患者接受 belantamab mafodotin 治疗,剂量为 2.5mg/kg,静脉注射,每 3 周一次。共有 27 名中位年龄为 65 岁(范围为 41-81 岁)的患者入组。其中,52%为男性,中位治疗线数为 5 线(4-10 线)。总体缓解率(部分缓解或更好)为 52%,而疾病控制率(稳定疾病或更好)为 70%。中位无进展生存期(PFS)为 2 个月(95%CI:0-7),而缓解者的中位 PFS 为 12 个月(95%CI:6-18)。关于毒性特征,最常见的毒性是眼毒性,占 44%的患者。33.3%的患者报告了 2-3 级角膜炎。总之,belantamab mafodotin 的安全性和疗效与注册研究结果一致。重要的是,对治疗有反应的大量预处理患者获得了显著的生存获益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c697/10380484/b841ef1fad45/ijms-24-11829-g001.jpg

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