The study, led by Dr. Yelena Janjigian, aims to generate the clinical data necessary to support a future international Phase III trial. Cadonilimab, a PD-1/CTLA-4 bispecific antibody, is being positioned as a superior alternative to current standards of care. While the FLOT chemotherapy regimen currently serves as the baseline, it produces a pathologic complete response rate of only 19%, leaving nearly one-third of patients at risk of recurrence or death within two years.

This trial builds on data from the Phase III COMPASSION-15 study and earlier neoadjuvant research. Beyond this gastric cancer initiative, Akeso is simultaneously expanding its US footprint by collaborating with the Dana-Farber Cancer Institute and Mass General Brigham to test cadonilimab in combination with DNA-based therapies for glioblastoma. These efforts underscore the company's strategy to utilize its bispecific antibody platform across diverse and aggressive oncological indications.