Akeso has entered into a collaboration with Memorial Sloan Kettering Cancer Center (MSKCC) to advance a Phase II clinical study evaluating a cadonilimab-based combination regimen for the perioperative treatment of locally advanced, resectable HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Cadonilimab is the world’s first PD-1/CTLA-4 bispecific antibody developed by Akeso.
The study is being led by Dr. Yelena Janjigian, a globally renowned expert in gastrointestinal malignancies at MSKCC. It is now actively enrolling patients across the United States.
This Phase II study will generate robust clinical evidence to support the future initiation of an international multicenter Phase III trial of the cadonilimab combination regimen for the perioperative treatment of GC/GEJ adenocarcinoma.
Cadonilimab and ivonescimab, as first-in-class bispecific antibodies with breakthrough global clinical value, have garnered significant attention and recognition from the international medical community. These innovative IO 2.0 therapies are increasingly favored by global partners as the preferred backbone for combination regimens and novel treatment paradigms across a wide range of cancers. Their global therapeutic value continues to be scientifically explored and realized through ongoing clinical data and new studies.
Building on cadonilimab’s unique dual-target synergistic mechanism, this Phase II study is supported by strong evidence from the Phase III COMPASSION-15 trial and previous Phase II neoadjuvant studies in gastric/GEJ adenocarcinoma.
Gastric cancer is the fifth most common malignancy worldwide, with nearly one million new cases annually. For patients with locally advanced, resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma, standard perioperative FLOT chemotherapy achieves a 3-year overall survival rate of only 48%.Â
Although the addition of PD-1 inhibitors to FLOT has become the new standard of care, the pathologic complete response (pCR) rate remains limited at approximately 19%, and nearly one-third of patients experience disease recurrence or death within two years. Dual PD-1/CTLA-4 inhibition has shown limited benefit due to overlapping toxicities and increased early mortality. A significant unmet medical need persists for more effective and better-tolerated treatment options.
As the first approved bispecific antibody for cancer immunotherapy, cadonilimab has demonstrated breakthrough clinical benefits across multiple pivotal studies and is now widely used in clinical practice. More than 12 registrational or Phase III studies of cadonilimab are currently underway globally, including two international multicenter registrational/Phase III trials led by Akeso.
In addition, Akeso is collaborating with INOVIO to explore a novel combination regimen using INOVIO’s DNA-based therapy for glioblastoma (GBM) at Dana-Farber Cancer Institute and Mass General Brigham. The Company continues to accelerate the global development of cadonilimab through strategic partnerships with leading therapeutics and institutions.
