双特异性抗体 epcoritamab 治疗 LBCL 取得积极结果,包括经 CAR-T 细胞疗法治疗失败的患者

2022-04-15 Allan MedSci原创

AbbVie 和 Genmab 表示,该队列的 ORR 为 63.1%,中位缓解持续时间为 12 个月。

生物制药公司艾伯维(AbbVie)和 Genmab 近日公布了一项 I / II 期试验的最新结果,该试验评估了双特异性抗体 epcoritamab 治疗复发/难治性大 B 细胞淋巴瘤(LBCL)患者的疗效,其中包括几名曾接受过 CAR-T 细胞疗法治疗的患者。根据 EPCORE NHL-1 试验的结果,两家公司打算“与监管机构合作以确定下一步行动,并继续在各种临床试验中评估 epcoritamab 治疗各种血液系统恶性肿瘤的有效性”。

EPCORE NHL-1 试验旨在评估 epcoritamab 在复发、进展或难治性 CD20+ 成熟 B 细胞淋巴瘤患者中的疗效,包括弥漫性大 B 细胞淋巴瘤 (DLBCL)。该研究队列包括 157 名复发/难治性 LBCL 患者,他们之前接受过中位 3.5 线治疗,其中近 40% 之前接受过 CAR-T 细胞治疗。试验的 II 期扩展部分的主要终点是由独立审查委员会评估的总缓解率 (ORR)。 AbbVie 和 Genmab 表示,该队列的 ORR 为 63.1%,中位缓解持续时间为 12 个月。

最常见的 3 级或 4 级治疗相关不良事件包括中性粒细胞减少症、贫血和血小板减少症。任何级别的细胞因子释放综合征 (CRS) 的发生率接近 50%,其中 3 级 CRS 的发生率为 2.5%。 

当两家公司在 2020 年建立合作伙伴关系以开发包括 epcoritamab 在内的下一代双特异性抗体,艾伯维向 Genmab 支付了 7.5 亿美元的预付款。作为交易的一部分,Genmab 还将获得高达 31.5 亿美元的里程碑式收益,以及在美国和日本以外的净销售额的 22%-26%。在正在进行的复发/难治性 DLBCL 患者的 III 期试验中,也正在评估 Epcoritamab 治疗复发/难治性 DLBCL 的总生存期(OS)。

 

原始出处:

https://firstwordpharma.com/story/5549767

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    2023-01-02 仁者大医
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Epcoritamab单药治疗复发性/难治性 B 细胞非霍奇金淋巴瘤的安全性和耐受性良好,而且展现出了初步的抗肿瘤活性