Hong Kong – September 27, 2026 -- Akeso, Inc. (9926.HK) has enrolled the first patient in COMPASSION-37, a global Phase III head-to-head trial testing its bispecific antibody cadonilimab against nivolumab as first-line treatment for HER2-negative advanced gastric and gastroesophageal junction (G/GEJ) adenocarcinoma.
Trial pits cadonilimab plus chemotherapy against nivolumab-based standard of care
The multicenter study compares cadonilimab combined with chemotherapy to chemotherapy with or without nivolumab in previously untreated, unresectable or metastatic G/GEJ patients. It is co-led by Dr. Yelena Y. Janjigian of Memorial Sloan Kettering Cancer Center, Professor Markus Möhler of Johannes Gutenberg University Mainz, and Professors Jiafu Ji and Lin Shen of Peking University Cancer Hospital. Janjigian, Möhler and Shen were investigators on the earlier CheckMate 649 trial, which established nivolumab plus chemotherapy as a global first-line standard.
PD-L1-low patients remain an unmet need despite immunotherapy adoption
Current NCCN and ESMO guidelines preferentially recommend nivolumab-based regimens for patients with PD-L1 CPS ≥5, leaving effective options scarce for PD-L1-low advanced gastric cancer. Janjigian said the trial aims to determine whether cadonilimab can extend survival benefits across this broader patient population.
COMPASSION-15 data showed survival benefit regardless of PD-L1 status
The Phase III COMPASSION-15 study enrolled 610 patients with HER2-negative advanced gastric or GEJ adenocarcinoma, including 49.8% with low PD-L1 expression and 23% PD-L1-negative — proportions exceeding comparable historical trials. Cadonilimab plus chemotherapy reduced the risk of death versus control across the overall population irrespective of PD-L1 status, providing the scientific basis for the global COMPASSION-37 validation trial.
Perioperative Phase II study already recruiting in the United States
Separately, a single-arm Phase II trial (NCT07631000) led by Janjigian at Memorial Sloan Kettering is enrolling U.S. patients to evaluate cadonilimab with FLOT chemotherapy as perioperative treatment for locally advanced, resectable G/GEJ adenocarcinoma. Results are expected to support a future international Phase III trial in the perioperative setting.
Cadonilimab already holds three China approvals
As the first approved bispecific antibody for cancer treatment, cadonilimab is currently approved in China for first-line gastric cancer, first-line cervical cancer, and recurrent/metastatic cervical cancer.