Multicenter phase 1b-2 trial of safety and activity of cadonilimab for advanced solid tumors

Immune checkpoint inhibitor targeting PD-1 or CTLA-4 individually have shown substantial clinical benefits in the treatment of malignancies. Cadonilimab is a bispecific antibody targeting both PD-1 and CTLA-4. The phase 1b-2 COMPASSION-03 trial, at 30 centers in China, evaluated cadonilimab for advanced solid tumors. The ORR was 32.3% in the cervical cancer cohort, 18.2% in the esophageal squamous cell carcinoma cohort, and 16.7% in the hepatocellular carcinoma cohort. There were promising survival outcomes among patients with cervical cancer and esophageal squamous cell carcinoma and among patients with hepatocellular carcinoma. The authors conclude that cadonilimab showed encouraging activity with a manageable safety profile.