China-based biopharmaceutical company Akeso, Inc. (HKG:9926) on Wednesday announced that the first patient has been enrolled and dosed in its Phase III clinical trial, COMPASSION-33, evaluating cadonilimab in combination with chemotherapy for the perioperative treatment of resectable gastric and gastro-oesophageal junction adenocarcinoma.

This marks the third Phase III trial of cadonilimab in gastric cancer and expands its potential use from unresectable advanced cases to resectable disease. The study aims to improve radical resection rates, lower recurrence and metastasis risks, and enhance overall outcomes for patients with advanced gastric cancer.

Cadonilimab, reportedly the world's first approved PD-1/CTLA-4 bispecific antibody, is already approved in China for first-line treatment of advanced gastric cancer, showing efficacy across all PD-L1 expression levels. A separate Phase III registration trial is also underway evaluating cadonilimab with pulocimab (VEGFR-2) for immune therapy-resistant advanced gastric cancer.

Currently, there are no approved perioperative immunotherapy treatment globally. Preliminary data suggests that cadonilimab may deliver superior efficacy and safety versus existing PD-1 therapies, including meaningful survival benefits for patients with low or negative PD-L1 expression where other treatments have shown limited effect.