Zhitong Finance App News, Weilizhibo-B (09887) announced that its self-developed Phase II clinical study on first-line treatment of locally advanced or metastatic gastric or gastroesophageal adenocarcinoma with Velisin® (opatisumimab, anti-PD-L1/4-1BB bispecific antibody) has completed a safety introduction period evaluation, showing positive efficacy signals, supporting it to enter the expansion phase. So far, clinical development of Villison ® in the field of gastrointestinal tumors has now covered five major tumors: biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), colorectal cancer (CRC), and gastric cancer (GC). Four of these studies have advanced to the expansion stage.
This study was led by Professor Shen Lin of Peking University Cancer Hospital and is progressing simultaneously at various hospitals across China. Based on the positive preliminary clinical data observed during the safety introduction period, after comprehensive evaluation by the sponsor and researchers, the study was supported to advance to the expansion stage of joint administration. The extended phase uses a randomized controlled trial design to directly compare the efficacy and safety of velisin® combined chemotherapy and tirelizumab in first-line treatment of locally advanced or metastatic gastric or gastroesophageal adenocarcinoma. The study will also explore the correlation between biomarkers in tumor tissue and efficacy to help define the groups of patients benefiting from the joint programme.