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新获批的抗 CD19 单克隆抗体治疗复发/难治性弥漫大 B 细胞淋巴瘤

英文原题:Newly approved anti-CD19 monoclonal antibodies for the treatment of relapsed or refractory diffuse large B-cell lymphoma.

查看英文原题

Newly approved anti-CD19 monoclonal antibodies for the treatment of relapsed or refractory diffuse large B-cell lymphoma.

PubMed 2022/01/17(内容时间) J Oncol Pharm Pract Q4 · IF 1.3(JCR 2025)

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中文摘要

本文总结近期获美国食品药品监督管理局(FDA)批准、用于复发/难治性(R/R)弥漫大B细胞淋巴瘤(DLBCL)的首批两种抗CD19单克隆抗体的研发背景、临床试验及其治疗定位。 摘要:对于自体干细胞移植(ASCT)或嵌合抗原受体(CAR)T细胞治疗后复发,或不适合接受上述治疗的患者,治疗选择有限。近期新疗法获批已开始改变这类患者的管理策略和结局。两种近期获FDA批准的药物为tafasitamab和loncastuximab tesirine,这是首批用于R/R DLBCL患者的抗CD19单克隆抗体。基于Ⅱ期L-MIND试验,tafasitamab联合来那度胺获加速批准,用于接受过一线或多线治疗的成人R/R DLBCL患者。基于Ⅱ期LOTIS-2试验,loncastuximab tesirine获加速批准,用于接受过两线或以上治疗的成人R/R DLBCL患者。这些药物的治疗定位和使用顺序会给处方决策带来挑战,尤其是在评估患者是否适合接受CD19靶向CAR-T 细胞治疗时。

tafasitamab和loncastuximab tesirine为R/R DLBCL患者提供了治疗选择,是有限治疗手段的重要补充。仍需更多数据明确药物使用顺序及其对CAR-T 细胞治疗可能产生的影响。目前临床试验正在研究这些药物在初治阶段与其他化学免疫疗法联合应用,这可能进一步扩大B细胞淋巴瘤的治疗选择。

展开英文摘要原文

Objective: This article summarizes the background, clinical trials, and place in therapy for the first two anti-CD19 monoclonal antibodies that have been recently FDA approved for patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Summary: Treatment options are limited for patients that have relapsed after or are ineligible for autologous stem cell transplant (ASCT) or chimeric antigen receptor (CAR) T-cell therapy. Recent novel therapy approvals have started to change management strategies and outcomes for these patients. Two examples of recent FDA approvals are tafasitamab and loncastuximab tesirine, which represent the first anti-CD19 targeting monoclonal antibodies for patients with R/R DLBCL.

Tafasitamab was granted accelerated approval in combination with lenalidomide for adult patients with R/R DLBCL after one or more lines of therapy based on the phase 2, L-MIND trial. Loncastuximab tesirine was granted accelerated approval for adult patients with R/R DLBCL after two or more lines of therapy based on the phase 2, LOTIS-2 trial.

The place in therapy and sequencing of these agents can present a challenge to prescribers especially in regards to patients being evaluated for CD19 targeting CAR T-cell therapy. Conclusion: Tafasitamab and loncastuximab tesirine are options for use in patients with R/R DLBCL and are welcome additions to the limited therapy options for these patients.

Further data is needed to elucidate sequencing and the impact these agents may have on CAR T-cell therapy. Ongoing clinical trials are studying these agents in the upfront setting in combination with other chemoimmunotherapy agents which may further expand treatment options for patients with B-cell lymphomas.

论文信息

作者
Davis JA、Shockley A、Glode AE
第一作者单位
Clinical Pharmacy Specialist - Malignant Hematology, MUSC Hollings Cancer Center, Charleston, SC, USA.United States
通讯作者单位
Department of Clinical Pharmacy, 15503University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA.United States
期刊
Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners2022 Apr
原文标识
PubMed 35037773 · DOI 10.1177/10781552211073575