Pembrolizumab Sustains 5-Year Survival Benefit in Cervical Cancer

Pembrolizumab plus platinum-based chemotherapy, with or without bevacizumab, maintained overall survival (OS) and progression-free survival (PFS) advantages at 5 years among patients with previously untreated persistent, recurrent, or metastatic cervical cancer, according to an exploratory analysis of the phase 3 KEYNOTE-826 randomized clinical trial published in JAMA Oncology.

The double-blind trial enrolled 617 female patients at 151 sites in 19 countries. Participants were randomly assigned to pembrolizumab 200mg every 3 weeks for up to 35 cycles or placebo, each given with platinum-based chemotherapy, with or without bevacizumab. The current ad hoc analysis had a median follow-up of 59.1 months, approximately 20 months beyond the trial’s final analysis. OS and PFS were the main outcomes. 

In the programmed cell death ligand 1 combined positive score (PD-L1 CPS) of at least 1 population, median OS was 28.6 months with pembrolizumab and 16.5 months with placebo (hazard ratio [HR], 0.62; 95% CI, 0.5-0.76). In the intention-to-treat population, median OS was 26.4 months and 16.8 months, respectively (HR, 0.64; 95% CI, 0.53-0.78).

The PFS advantage also persisted in both populations. Median PFS in the PD-L1 CPS of at least 1 population was 10.5 months with pembrolizumab and 8.2 months with placebo (HR, 0.58; 95% CI, 0.48-0.71). Corresponding results in the intention-to-treat population were 10.4 and 8.2 months (HR, 0.61; 95% CI, 0.51-0.74).

No new safety signals were observed, and no additional deaths attributed to treatment-related adverse events had occurred since the final analysis. The investigators characterized the follow-up evaluation as ad hoc and exploratory. They concluded that the 5-year findings confirmed durable benefit and reinforced pembrolizumab plus chemotherapy, with or without bevacizumab, as a first-line standard-of-care option for recurrent and metastatic cervical cancer.

Source: Hasegawa K, Colombo N, Tewari KS, et al. Pembrolizumab plus chemotherapy for cervical cancer: an exploratory analysis of the KEYNOTE-826 randomized clinical trial. JAMA Oncol. Published online September 10, 2026. doi:10.1001/jamaoncol.2026.3547