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Cadonilimab (PD-1/CTLA-4) Receives FDA Clearance for Global Phase III First-Line Gastric Cancer Trial Versus Nivolumab
The global Phase III COMPASSION-37 trial will test cadonilimab plus chemotherapy against chemotherapy with or without nivolumab in HER2-negative gastric cancer patients.
- Dec. 11, 2025, Akeso, Inc. said the FDA cleared its global Phase III COMPASSION-37/AK104-311 trial testing cadonilimab, a PD-1/CTLA-4 bispecific antibody, in first-line HER2-negative unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma.
- COMPASSION-15's China approval in 2024, which showed benefit across PD-L1 groups, prompted global development as treating PD-L1 low expression and PD-L1-negative patients remains a clinical challenge.
- Long-Term follow-up showed a 39% mortality reduction with cadonilimab plus chemotherapy overall , reaching 51% in the PD-L1 CPS e5 subgroup , enrolling 49.8% low and 23% PD-L1-negative patients.
- Launching COMPASSION-37 advances cadonilimab's global registrational plan and reinforces Akeso's leadership, as the second international registrational study follows an ongoing hepatocellular carcinoma trial, Akeso said.
- After ESMO 2025 and earlier AACR 2024 exposure, Akeso emphasized forward-looking risks, framing the announcement as containing forward-looking statements with no assurance of future approvals.
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Cadonilimab (PD-1/CTLA-4) Receives FDA Clearance for Global Phase III First-Line Gastric Cancer Trial Versus Nivolumab
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…
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