Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors

作者：Jian Li, Yanhong Deng, Weijie Zhang, Aiping Zhou, Weijian Guo, Jianwei Yang, Ying Yuan, Liangjun Zhu, Shukui Qin, Silong Xiang, Haolan Lu, John Gong, Ting Xu, David Liu, Lin Shen · 发表于：Journal of Hematology & Oncology · 年份：2021 · DOI：10.1186/s13045-021-01095-1 · 被引用次数：151 · 研究领域：Genetic factors in colorectal cancer、Cancer Immunotherapy and Biomarkers、Colorectal Cancer Treatments and Studies

BACKGROUND: Monoclonal antibodies targeting programmed death ligand 1 (PD-L1) signaling currently approved for defective mismatch repair (dMMR)/microsatellite instability high (MSI-H) tumors must be delivered by intravenous infusion. Envafolimab, a humanized single-domain anti-PD-L1 antibody fused to an Fc fragment, represents a potential advance because it can be conveniently administered subcutaneously. METHODS: This open-label, single-arm, phase 2 study evaluated the efficacy and safety of envafolimab in patients with previously treated advanced dMMR/MSI-H tumors from 25 clinical sites across China. Adults with histologically confirmed locally advanced or metastatic malignant dMMR/MSI-H solid tumors received weekly 150 mg subcutaneous envafolimab injections in a 28-day treatment cycle. The primary efficacy endpoint was the objective response rate (assessed by a blinded independent review committee). Secondary efficacy outcomes were disease control rate, duration of response, progression-free survival, and overall survival. RESULTS: One hundred and three patients (65 with colorectal cancer, 18 with gastric cancer, and 20 with other solid tumors) were enrolled. Median follow-up was 11.5 months. The objective response rate was 42.7% (95% confidence interval [CI] 33.0-52.8), and the disease control rate was 66.0% (95% CI 56.0-75.1). Median duration of response was not reached; the duration of response rate at 12 months was 92.2% (95% CI 77.5-97.4). Median progression-free surv...