Efficacy, safety and genomic analysis of SCT200, an anti-EGFR monoclonal antibody, in patients with fluorouracil, irinotecan and oxaliplatin refractory RAS and BRAF wild-type metastatic colorectal cancer: a phase Ⅱ study

作者：Lin Yang, Wen Zhang, Nanfeng Fan, Peiguo Cao, Ying Cheng, Lingjun Zhu, Suxia Luo, Hong Zong, Yuxian Bai, Jianfeng Zhou, Yanhong Deng, Yi Ba, Tianshu Liu, Mayinuer Aili, Xianli Yin, Kangsheng Gu, Guanghai Dai, Jieer Ying, Jianhua Shi, Yajie Gao, Wěi Li, Guohua Yu, Liangzhi Xie, Wenlin Gai, Yan Wang, Peng Meng, Yuankai Shi · 发表于：EBioMedicine · 年份：2024 · DOI：10.1016/j.ebiom.2024.104966 · 被引用次数：10 · 研究领域：Colorectal Cancer Treatments and Studies、HER2/EGFR in Cancer Research、Cancer Cells and Metastasis

BACKGROUND: Limited therapeutic options are available for metastatic colorectal cancer (mCRC) patients after failure of first- and second-line therapies, representing an unmet medical need for novel therapies. METHODS: This is an open-label, single arm, multicenter, phase Ⅱ study aiming to perform the efficacy, safety and genomic analysis of SCT200, a noval fully humanized IgG1 anti-epidermal growth factor receptor (EGFR) monoclonal antibody, in patients with fluorouracil, irinotecan and oxaliplatin refractory RAS and BRAF wild-type mCRC. SCT200 (6 mg/kg) was given weekly for the first six weeks, followed by a higher dose of 8 mg/kg every two weeks until disease progression or unacceptable toxicity. Primary endpoint was independent review committee (IRC)-assessed objective response rate (ORR) and secondary endpoints included ORR in patients with left-sided tumor, disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and safety. FINDINGS: From February 12, 2018 to December 1, 2019, a total of 110 patients aged between 26 and 77 years (median: 55; interquartile range [IQR]: 47-63) with fluorouracil, oxaliplatin, and irinotecan refractory RAS and BRAF wild-type mCRC were enrolled from 22 hospitals in China. As the data cut-off date on May 15, 2020, the IRC-assessed ORR and DCR was 31% (34/110, 95% confidence interval [CI] 22-40%) and 75% (82/110, 95% CI 65-82%), respectively. Thirty one percent (34/...