Multicenter phase 3 trial of first-line cadonilimab plus chemotherapy with or without bevacizumab for persistent, recurrent, or metastatic cervical cancer

Cadonilimab is a bispecific antibody targeting PD-1 and CTLA-4. The phase 3 COMPASSION-16 trial, at 59 centers in China, evaluated addition of cadolimab to standard first-line platinum-based chemotherapy with or without bevacizumab for persistent, recurrent, or metastatic cervical cancer. Patient were randomized to cadonilimab or placebo, added to standard first-line treatment for six 3-week cycles, followed by cadonilimab or placebo maintenance for up to two years. Median progression-free survival was 12.7 months in the cadonilimab group and 8.1 months in the placebo group (HR 0.62; p<0.0001) and median overall survival was not reached in the cadonilimab group and 22.8 months in the placebo group (HR 0.64; p=0.0011). The most common grade 3 or higher adverse events were decreased neutrophil count, decreased white blood cell count, and anemia. The authors conclude that the addition of cadonilimab to standard first-line treatment significantly improved PFS and OS with a manageable safety profile in patients with persistent, recurrent, or metastatic cervical cancer.