FDA Clears Akeso Inc. to Begin Global Phase III Trial of Cadonilimab in First-Line Gastric Cancer

Reuters12-12

FDA Clears Akeso Inc. to Begin Global Phase III Trial of Cadonilimab in First-Line Gastric Cancer

Akeso Inc. has received FDA clearance to initiate the COMPASSION-37/AK104-311 global Phase III trial evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody, for first-line treatment of HER2-negative, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma. The study will compare cadonilimab plus chemotherapy to chemotherapy with or without nivolumab. This marks Akeso's second international registrational study for cadonilimab and represents a significant milestone in the company's global development strategy.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Akeso Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN45248) on December 12, 2025, and is solely responsible for the information contained therein.

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