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Cadonilimab (PD-1/CTLA-4) Receives FDA Clearance for Global Phase III First-Line Gastric Cancer Trial Versus Nivolumab
Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced FDA approval to initiate COMPASSION-37/AK104-311 trial, a global multicenter Phase III trial in gastric cancer evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody. The study will compare cadonilimab plus chemotherapy against chemotherapy with or without nivolumab as first-line treatment for HER2-negative, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma.
About this update from Akeso, Inc.
[{"type":"text","content":"HONG KONG, Dec. 11, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced FDA approval to initiate COMPASSION-37/AK104-311 trial, a global multicenter Phase III trial in gastric cancer evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody. The study will compare cadonilimab plus chemotherapy against chemotherapy with or without nivolumab as first-line treatment for HER2-negative, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma.","length":524,"tagName":"p"},{"type":"text","content":"This is the second international registrational study for cadonilimab, following the ongoing trial in immunotherapy-resistant hepatocellular carcinoma. COMPASSION-37 represents a pivotal advancement in cadonilimab's global development and a concrete step in Akeso's worldwide strategy, reinforcing its leadership in next-generation immuno-oncology. The company remains committed to its dual-track approach of proprietary development and strategic collaboration, leveraging global resources to accelerate cadonilimab's international availability and expand accessible treatment options for patients worldwide.","length":620,"tagName":"p"},{"type":"text","content":"Chemotherapy with or without PD-1 inhibitors, such as nivolumab, represents the international standard of care for advanced gastric cancer. However, the disease exhibits significant heterogeneity. While PD-1 treatment in combination with chemotherapy remains an effective treatment in many gastric cancer patients with high PD-L1 expression (CPS >5), its efficacy is markedly limited in gastric cancer patients with low PD-L1 expression (CPS <5) or negative PD-L1 expression (CPS <1). These low and negative PD-L1 patients constitute well more than half of the total gastric cancer patient population.","length":610,"tagName":"p"},{"type":"text","content":"In 2024, the FDA narrowed the indication for all approved PD-1 inhibitors in the first-line treatment of advanced gastric cancer, restricting their use to PD-L1-positive patients. Authoritative guidelines, including those from the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO), also prioritize recommending nivolumab-based regimens for patients with PD-L1 CPS ≥5. This underscores that treating a...