Standard chemotherapy before and after surgery for locally advanced stomach cancer leaves fewer than half of patients alive three years later. The figure is 48%, according to Akeso, and it is the number behind a new U.S. study the company announced on July 14.
Akeso, the Hong Kong-listed maker of cadonilimab, is working with Memorial Sloan Kettering Cancer Center on a Phase II trial of a cadonilimab-based regimen. Dr. Yelena Janjigian, a gastrointestinal cancer specialist at the center, leads it. Patients across the United States are now being enrolled.
Who is eligible
The study is open to adults with locally advanced, resectable HER2-negative gastric or gastroesophageal junction adenocarcinoma. The regimen is given around surgery. Cadonilimab is a bispecific antibody that blocks both PD-1 and CTLA-4 in one molecule.
The case Akeso makes
Gastric cancer is the fifth most common malignancy worldwide, with nearly a million new cases a year, the company says. Adding a PD-1 inhibitor to FLOT chemotherapy has become the new standard of care. Even so, only about 19% of patients have a pathologic complete response, meaning no detectable cancer in the removed tissue, and nearly a third have a recurrence or die within two years.
Akeso also notes that earlier attempts to block PD-1 and CTLA-4 together showed limited benefit because the toxicities overlapped and early deaths rose. It argues that a need for more effective, better-tolerated options remains.
The Phase II study builds on Akeso’s Phase III COMPASSION-15 trial and on earlier Phase II work in the neoadjuvant setting. If it goes well, the data would support an international multicenter Phase III trial.
The company says more than 12 registrational or Phase III studies of cadonilimab are running worldwide, two of them international multicenter trials led by Akeso. No results from the new study have been released, and how the combination works in this group of patients is not yet known. Patients considering any trial should discuss it with their doctor.
Sources
- Akeso launches US Phase II cadonilimab study in gastric cancer
- Phase II Trial of Cadonilimab(PD-1/CTLA-4) Combination Regimen Launches in the United States for Perioperative Treatment of Gastric Cancer
