[在中国的晚期固体瘤患者中进行皮下用恩瓦福利马布 (KN035) 单疗法的一期研究]
1Department of Medical Oncology, Senior Department of Oncology, the Fifth Medical Center of PLA General Hospital, Beijing 100071, China.
Zhonghua zhong liu za zhi [Chinese journal of oncology]
|October 24, 2023
概括
恩瓦福利马布单疗法在中国患者中表现出良好的安全性和有前途的抗瘤活性,这些患者患有晚期固体瘤. 这种皮下治疗在I期试验中显示出可管理的不良事件和令人鼓舞的反应率.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 临床药理学 临床药理学
背景情况:
- 先进的固体瘤代表着一个重要的未满足的医疗需求.
- 免疫疗法已成为各种癌症的有希望的治疗方式.
- 评估像恩瓦福利马布这样的新型治疗药物对于扩大治疗选择至关重要.
研究的目的:
- 评估恩瓦福利马布单独治疗的安全性和抗瘤疗效.
- 为了确定进一步临床试验的推剂量.
- 描述恩瓦福利马布的药物动力学特征.
主要方法:
- 开放式,多中心的I期试验,包括剂量升级和扩展阶段.
- 恩瓦福利马布每周一次以0.1至10.0毫克/公斤的剂量进行皮下注射.
- 通过治疗出现的不良事件 (TEAE) 和与免疫相关的不良反应 (irAE) 评估安全性;通过客观反应率 (ORR) 和疾病控制率 (DCR) 评估有效性.
主要成果:
- 没有观察到剂量限制性毒性;75.3%的患者经历了任何级别的TEAE,20.6%经历了3级或4级的TEAE.
- 常见的irrAEs包括甲状腺功能低下症,甲状腺功能过高症,免疫相关性肝炎和皮疹;注射部位反应不频繁且低度.
- 在可评估疗效的患者中,ORR为11.6%,DCR为43.1%,反应的中位持续时间为49.1周.
结论:
- 皮下使用的恩瓦福利马布在中国患者中表现出良好的安全性,这些患者患有晚期固体瘤.
- 该药物表现出有希望的初步抗瘤活性.
- 第一阶段的结果支持在这个患者群体中对恩瓦福利马布的进一步研究.
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