ARX788 单药治疗 HER2 阳性晚期胃及胃食管结合部腺癌的 1 期多中心剂量扩展研究。
Phase 1 multicenter, dose-expansion study of ARX788 as monotherapy in HER2-positive advanced gastric and gastroesophageal junction adenocarcinoma.
机构信息
Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University, Guangzhou 510060, P.R. China.
Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University, Guangzhou 510060, P.R. China; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou 510060, P.R. China.
出版信息
Cell Rep Med. 2022 Nov 15;3(11):100814. doi: 10.1016/j.xcrm.2022.100814.
ARX788 is an anti-human epidermal growth factor receptor 2 (HER2) antibody-drug conjugate with AS269 as cytotoxic payload. In this phase 1 multicenter dose-expansion clinical trial, patients with HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma failing to respond to prior trastuzumab-based standard treatment were enrolled. Between July 15, 2019, and March 14, 2022, 30 participants were enrolled. Twenty-eight (93.3%) patients experienced at least one drug-related adverse event (AE) and 13.3% experienced grade 3 ARX788-related AEs. The confirmed objective response rate is 37.9% (95% confidence interval [CI]: 20.7%-57.7%) and the disease control rate is 55.2% (95% CI: 35.7%-73.6%). With a median follow up of 10 months, the median progression-free survival and overall survival are 4.1 (95% CI: 1.4-6.4) and 10.7 months (95% CI: 4.8-not reached), respectively. The median duration of response is 8.4 (95% CI: 2.1-18.9) months. ARX788 is well tolerated and has promising anti-tumor activity in patients with HER2-positive advanced gastric adenocarcinoma (ChinaDrugTrials.org.cn: CTR20190639).
ARX788 是一种抗人表皮生长因子受体 2（HER2）抗体药物偶联物，其细胞毒性有效载荷为 AS269。在这项多中心 1 期剂量扩展临床试验中，入组了先前曲妥珠单抗标准治疗失败的 HER2 阳性晚期胃/胃食管交界处腺癌患者。2019 年 7 月 15 日至 2022 年 3 月 14 日期间，共入组 30 名患者。28 名（93.3%）患者至少经历了一次与药物相关的不良事件（AE），13.3%的患者经历了 3 级 ARX788 相关 AE。确认的客观缓解率为 37.9%（95%置信区间[CI]：20.7%-57.7%），疾病控制率为 55.2%（95%CI：35.7%-73.6%）。中位随访 10 个月时，中位无进展生存期和总生存期分别为 4.1（95%CI：1.4-6.4）和 10.7 个月（95%CI：4.8-未达到）。中位缓解持续时间为 8.4（95%CI：2.1-18.9）个月。ARX788 耐受性良好，在 HER2 阳性晚期胃腺癌患者中具有有前景的抗肿瘤活性（ChinaDrugTrials.org.cn： CTR20190639）。
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