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Loncastuximab tesirine 用于弥漫性大 B 细胞淋巴瘤。

Loncastuximab tesirine for diffuse large B-cell lymphoma.

机构信息

Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.

出版信息

Drugs Today (Barc). 2021 Dec;57(12):733-743. doi: 10.1358/dot.2021.57.12.3352741.

Abstract

Loncastuximab tesirine-lpyl (ADC Therapeutics), an anti-CD19 antibody-drug conjugate, was recently approved for the treatment of relapsed, refractory diffuse large B-cell lymphoma on the basis of the results of a phase II clinical trial, LOTIS-2. Preclinical data demonstrated the selectivity and efficacy of the drug through in vitro and in vivo models. A phase I clinical trial included relapsed, refractory B-cell non-Hodgkin lymphoma (NHL) and demonstrated a tolerable safety profile, with major adverse effects being neutropenia, thrombocytopenia and elevated gamma-glutamyl transferase (GGT). A dose of 150 μg/kg intravenously every 3 weeks for two cycles followed by 75 μg/kg every 3 weeks was chosen for further testing. The phase II trial, LOTIS-2, recruited relapsed, refractory diffuse large B-cell lymphoma patients and demonstrated no new safety concerns. Overall response rate was 48.3% (24.1% CR), and OS was 9.9 months. Currently, several ongoing clinical trials are evaluating the safety and efficacy of loncastuximab tesirine in a variety of NHL subtypes.

摘要

Loncastuximab tesirine-lpyl(ADC Therapeutics)是一种抗 CD19 抗体药物偶联物,基于 LOTIS-2 期临床试验结果,最近被批准用于治疗复发/难治性弥漫性大 B 细胞淋巴瘤。临床前数据通过体外和体内模型证明了药物的选择性和疗效。一项包含复发/难治性 B 细胞非霍奇金淋巴瘤(NHL)的 1 期临床试验显示出可耐受的安全性特征,主要不良反应为中性粒细胞减少症、血小板减少症和γ-谷氨酰转移酶(GGT)升高。选择静脉注射 150μg/kg,每 3 周 2 个周期,然后每 3 周 75μg/kg 用于进一步检测。2 期临床试验 LOTIS-2 招募了复发/难治性弥漫性大 B 细胞淋巴瘤患者,未发现新的安全性问题。总体缓解率为 48.3%(24.1%完全缓解),OS 为 9.9 个月。目前,多项正在进行的临床试验正在评估 loncastuximab tesirine 在各种 NHL 亚型中的安全性和疗效。

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