Envonalkib与crizotinib对未经治疗的ALK阳性非小细胞肺癌:一个随机的,多中心的,开放的,第三阶段试验
Yunpeng Yang1, Jie Min2, Nong Yang3
1Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, China.
Envonalkib显著改善了晚期形淋巴瘤激酶 (ALK) 阳性非小细胞肺癌 (NSCLC) 的无进展生存率. 与crizotinib相比,这种新型ALK抑制剂在延缓中枢神经系统转移方面也显示出有前途.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 无细胞淋巴瘤激酶 (ALK) 的重组发生在5-6%的非小细胞肺癌 (NSCLC) 病例中.
- ALK重组与中枢神经系统 (CNS) 参与的风险更高有关.
研究的目的:
- 评估一线envonalkib与crizotinib相比在先进的ALK阳性NSCLC中的疗效和安全性.
- 评估无进展生存 (PFS),客观反应率 (ORR),中枢神经系统反应和整体生存 (OS).
主要方法:
- 一个第三阶段的随机 1:1 控制试验 (NCT04009317) 涉及264名参与者.
- 参与者接受了envonalkib (n=131) 或crizotinib (n=133).
- 结果由独立审查委员会 (IRC) 评估.
主要成果:
- 中位数的PFS显著长于Envonalkib (24.87个月),而不是crizotinib (11.60个月) (HR=0.47,p<0.0001).
- 经IRC评估的ORR较高的是envonalkib (81.68%) 和crizotinib (70.68%).
- 在基线脑病变患者中,Envonalkib (78.95%) 与crizotinib (23.81%) 相比,CNS-ORR显著改善.
结论:
- 在先进的ALK阳性NSCLC中,一线envonalkib显示了与crizotinib相比更好的PFS和中枢神经系统疗效.
- 虽然OS数据还不成熟,但envonalkib显示出作为这种患者群体的新治疗选择的潜力.
- 与Envonalkib (55.73%) 与crizotinib (42.86%) 相比,与治疗相关的3级以上不良事件的发生率更高.
更多相关视频
06:51Utilizing 18F-FDG PET/CT Imaging and Quantitative Histology to Measure Dynamic Changes in the Glucose Metabolism in Mouse Models of Lung Cancer
Published on: July 21, 2018
10:49Pre-clinical Evaluation of Tyrosine Kinase Inhibitors for Treatment of Acute Leukemia
Published on: September 18, 2013
相关概念视频
Treatment Resistant Cancers
Clinical Trials: Overview
Clinical Trials
There are four phases in a clinical trial. A phase one...
Cancer Therapies
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...
Chemotherapy-Induced Nausea and Vomiting: Neurokinin-1 Receptor Antagonists
Targeted Cancer Therapies
There are several types of targeted therapies against...
