Overall survival in a multinational phase 3 trial of first-line pembrolizumab plus chemotherapy for persistent, recurrent, or metastatic cervical cancer

The phase 3 KEYNOTE-826 trial of pembrolizumab 200 mg or placebo once every 3 weeks for up to 35 cycles plus platinum-based chemotherapy with or without bevacizumab, showed statistically significant survival benefits with the addition of pembrolizumab among patients with persistent, recurrent, or metastatic cervical cancer. Analysis of final overall survival results found that after median follow-up of 39.1 months, the median overall survival was 38.6 months with pembrolizumab versus 16.8 months with placebo among patients with PD-L1 combined positive score 1 or higher (HR 0.60; 95% CI 0.49-0.74). Among all patients, the median OS was 26.4 months with pembrolizumab versus 16.8 months with placebo (HR 0.63; 95% CI 0.52-0.77), and among patients with CPS 10 or higher median OS was 29.6 months with pembrolizumab versus 17.4 months with placebo (0.58; 0.44-0.78). The incidence of grade 3 or higher adverse events was 82.4% in the pembrolizumab group and 75.4% in the placebo group. The authors conclude that among patients with persistent, recurrent, or metastatic cervical cancer, addition of pembrolizumab to chemotherapy with or without bevacizumab continued to provide clinically meaningful improvements in OS.