Multinational phase 2 study of second-line balstilimab plus zalifrelimab for advanced cervical cancer

Patients with advanced cervical cancer and progression after platinum-based therapy have an unmet medical need and lack of effective therapies. A multinational phase 2 study evaluated the combination of balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) as second-line treatment for advanced cervical cancer. The confirmed ORR was 25.6% (95% CI 18.8-33.9) including complete response in 8%, with median duration of response not reached during median follow-up of 21 months. The ORRs were 32.8% and 9.1% among patients with PD-L1 positive and PD-L1 negative tumors, respectively.