Gls-010, a novel anti-PD-1 mAb in Chinese advanced gastrointestinal tumor: Result of a phase Ib clinical trial.

作者：Shen Lin, Jifang Gong, Yingying Xu, Xiaotian Zhang, Zhi Peng, Changsong Qi, Guochun Li, Haijin Meng, Zhen Liu, Hui Wang, Christopher S. Chen, Jing Li, Yong Zheng, Johnathan Lee, Yan Zhang, Qiang Zhang, Ge Jin, Yining Yang, Guodong Zhao · 发表于：Journal of Clinical Oncology · 年份：2019 · DOI：10.1200/jco.2019.37.4_suppl.125 · 被引用次数：10 · 研究领域：Cancer Immunotherapy and Biomarkers、Gastric Cancer Management and Outcomes、Lung Cancer Treatments and Mutations

125 Background: GLS-010 is a novel fully human anti-PD-1 mAb. Phase Ia exhibited good result of tolerance and 240mg fixed dose was selected. Phase Ib is to explore efficacy and biomarkers in different types of advanced cancer. Here we report the preliminary result in Chinese gastrointestinal (GI) tumor patients (pts) from the phase Ib. Methods: All pts enrolled received GLS-010 240mg every 2 weeks. Tumor response was assessed by RECIST 1.1 every 8 weeks. Adverse events (AEs) were graded by NCI CTCAE v4.03. Several biomarkers were evaluated, including PD-L1 by IHC, tissue tumor mutation burden (tTMB) by whole exome sequencing (WES) from FFPE tissue, blood TMB (bTMB) by the multi-gene panel based next-generation sequencing (NGS) from blood ctDNA. Results: Until September 2018, 23 pts (including 10 gastric cancer or GC, 10 esophagus cancer or EC, and 3 biliary tract cancer or BTC) were enrolled in the phase 1b. The median dosing number was 4 (range: 1~16). The most common treatment related AEs included haemoglobin decreased (16/23, G1-2), leukopenia (6/23, G1-2), fever (4/23, G1), blood bilirubin increased (4/23, G1-3), ALT increased (3/23, G1), etc. Treatment–related grade 3-5 AEs include 1 multiple organ dysfunction syndrome, 1 interstitial lung disease and 1 blood bilirubin increased. 21 pts received response evaluation. Four patients achieved partial response (PR), including 1 GC (1/9), 2 EC (2/10), and 1 BTC (1/2). 2 subjects had stable disease (SD) at Week 8, and were stil...