The addition of pembrolizumab to chemotherapy with or without (+/-) bevacizumab significantly improves progression-free survival (PFS) and overall survival (OS) in East Asian patients with persistent, recurrent or metastatic cervical cancer, according to the exploratory analysis of the final results from the phase III KEYNOTE-826 trial.
At the final analysis of the KEYNOTE-826 trial, the median PFS in the pembrolizumab plus chemotherapy arm was 10.4 months vs 8.2 months in the placebo plus chemotherapy +/- bevacizumab arm (hazard ratio [HR], 0.61; 95 percent confidence interval [CI], 0.50–0.74), while the median OS was 26.4 vs 16.8 months (HR, 0.63; 95 percent CI, 0.52–0.77) in the intention-to-treat (ITT) population (n=617). [N Engl J Med 2021;385:1856-1867]
The present exploratory analysis focused on the dual primary endpoints of PFS and OS among the 97 patients from East Asia, namely, Japan (n=57), Republic of Korea (n=24) and Taiwan (n=16). Of these, 87 patients had PD-L1 combined positive score (CPS) ≥1. Median duration of follow-up was 39.8 months for both the ITT and PD-L1 CPS ≥1 populations. [J Gynecol Oncol 2025;36:e110]
The median PFS with pembrolizumab vs placebo plus chemotherapy +/- bevacizumab was 18.0 vs 10.4 months in the ITT (HR, 0.42; 95 percent CI, 0.23–0.77) and 29.3 vs 10.9 months in the PD-L1 CPS ≥1 (HR, 0.36; 95 percent CI, 0.19–0.68) populations of East Asian patients. Similarly, the addition of pembrolizumab to chemotherapy +/- bevacizumab prolonged the median OS in both the ITT (not reached [NR] vs 20.4 months; HR, 0.53; 95 percent CI, 0.28–0.99) and PD-L1 CPS ≥1 (NR vs 17.4 months; HR, 0.43; 95 percent CI, 0.22–0.86) populations.
In the ITT population of East Asian patients, the objective response rate (ORR) was 77 and 68 percent in the pembrolizumab and placebo groups, respectively, while in the PD-L1 CPS ≥1 population, the ORR was 80 and 68 percent, respectively. “More participants achieved a complete response in the pembrolizumab plus chemotherapy group vs the placebo plus chemotherapy [+/- bevacizumab] group in both the ITT [35 vs 23 percent] and PD-L1 CPS ≥1 [40 vs 24 percent] populations,” noted the investigators.
Adverse events (AEs) were reported in all patients in both treatment groups, with grade 3–5 AEs observed in 95 percent of patients in each group. The most common AEs of any grade (occurring in ≥50 percent of patients overall) were alopecia (pembrolizumab plus chemotherapy +/- bevacizumab, 75 percent; placebo plus chemotherapy +/- bevacizumab, 68 percent), anaemia (67 and 65 percent), peripheral sensory neuropathy (54 and 70 percent), and decreased neutrophil count (53 and 53 percent). Discontinuation of any study treatments due to AEs occurred in 51 percent of patients on pembrolizumab and 33 percent of patients who received placebo. “The safety profile of pembrolizumab plus chemotherapy +/- bevacizumab in this exploratory subgroup analysis was generally consistent with that for the global population,” commented the investigators.
“Our results provide support for the use of pembrolizumab plus chemotherapy +/- bevacizumab as a standard-of-care treatment for patients from East Asia with persistent, recurrent or metastatic cervical cancer,” they concluded.