Akeso has launched a Phase II clinical study in the United States evaluating a cadonilimab-based combination regimen for perioperative treatment of gastric cancer.
The study is being conducted in collaboration with Memorial Sloan Kettering Cancer Center and is led by Dr Yelena Janjigian, a specialist in gastrointestinal malignancies. It is enrolling patients with locally advanced, resectable HER2-negative gastric or gastroesophageal junction adenocarcinoma.
This is relevant because gastric cancer remains a high-burden malignancy with limited long-term outcomes in locally advanced disease. Standard perioperative FLOT chemotherapy achieves a 3-year overall survival rate of only 48 per cent, leaving room for more effective treatment strategies.
Cadonilimab is Akeso’s PD-1/CTLA-4 bispecific antibody. It is designed to combine checkpoint blockade against two immune pathways in a single molecule, potentially offering a differentiated approach compared with separate antibody combinations.
The Phase II study will generate clinical evidence to support a potential international multicentre Phase III trial. It builds on evidence from Akeso’s Phase III COMPASSION-15 trial and prior Phase II neoadjuvant studies in gastric and gastroesophageal junction adenocarcinoma.
The U.S. launch is strategically important because it expands cadonilimab’s development beyond China and into a major global oncology research setting. Collaboration with Memorial Sloan Kettering may also support stronger international clinical validation.
