Chinese pharmaceutical company Akeso Inc (HK:9926) announced on Sunday that the first patient has been enrolled in COMPASSION-37 (AK104-311), a global, multicentre Phase III head-to-head trial evaluating cadonilimab, Akeso's first-in-class PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy versus chemotherapy with or without nivolumab, as first-line treatment for patients with HER2-negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

This study is designed to further evaluate the efficacy and safety of cadonilimab as first-line therapy for advanced gastric cancer across geographically and ethnically diverse patient populations worldwide, and to investigate whether dual PD-1/CTLA-4 immune checkpoint blockade can further improve outcomes beyond the current standard of care.

Cadonilimab is currently approved in China for first-line gastric cancer, first-line cervical cancer, and recurrent/metastatic cervical cancer, and is widely used in clinical practice. Cadonilimab is being evaluated in more than 13 registrational or Phase III trials globally, spanning major tumour types including gastric, liver, lung, cervical, and pancreatic cancers.