Authors:

Li Shen¹, Carol Mao¹, Alan Lin¹ , Jenny Milata², Lijuan Zhang¹, Chuan Qi¹, Jenny Yao², Changjun Yue³, Lin Shen⁴, Yelena Janjigian⁵，Xueming Qian¹, Wen-I Chang², Li Xu², Caroline Germa² 

¹Suzhou Transcenta Therapeutics Co., Ltd, Suzhou, Jiangsu, P. R. China，²Transcenta Therapeutics, Princeton, NJ, USA，³LabCorp Central Laboratory, Torrance, CA, USA，⁴Beijing Cancer Hospital, Beijing, P. R. China，⁵Memorial Sloan Kettering Cancer Center, New York, NY, USA

Background:

Claudin18.2 (CLDN18.2) is a tight junction protein highly specific to gastric mucosa, and a validated target for gastric cancer (GC) treatment. Immune checkpoint therapy targeting PD-1 combined with chemotherapy has been approved as the first line therapy of GC. Understanding the expression profiles of CLDN18.2 and PD-L1 could guide the development of combination therapies to maximize the benefits of these two agents. This study investigated the prevalence of CLDN18.2 expression in gastric/gastroesophageal junction adenocarcinoma (G/GEJC) screening samples from studies Transtar101 (NCT04396821 in US) and TranStar102 (NCT04495296 in China), and its correlation with various clinical characteristics and PD-L1 expression.

Conclusions:

Data suggested CLDN18.2 expression levels were independent of PD-L1 status, and support the use of Transcenta 14G11 antibody for CLDN18.2 detection regardless of sample collection methods, location, and patient demographics. An anti-CLDN18.2 companion diagnostic device based on 14G11 is being developed (CLDN18.2 IHC 4G11 pharmDx, Agilent Technologies, Inc.)