In an analysis reported in the Journal of Clinical Oncology, Bradley J. Monk, MD, FACS, FACOG, and colleagues described final overall survival results from the phase III KEYNOTE-826 trial, which evaluated the addition of first-line pembrolizumab to chemotherapy, with or without bevacizumab, in patients with persistent, recurrent, or metastatic cervical cancer.
The trial supported the October 2021 approval of pembrolizumab in combination with chemotherapy, with or without bevacizumab, in this setting among patients with a PD-L1 combined positive score (CPS) of ≥ 1. The pembrolizumab-based regimen was associated with significantly improved overall survival (hazard ratio [HR] = 0.64, P = .0001) and progression-free survival in this subgroup of patients.
Study Details
In the double-blind trial, 617 patients were randomly assigned to receive either pembrolizumab at 200 mg (n = 308) or placebo (n = 309) every 3 weeks for up to 35 cycles. All patients received chemotherapy (paclitaxel at 175 mg/m2 plus either cisplatin at 50 mg/m2 or carboplatin at area under the curve = 5) once every 3 weeks for six cycles; patients could receive bevacizumab at 15 mg/kg every 3 weeks according to local practice at investigator’s discretion.
The current final analysis of overall survival describes results among all 617 patients, 548 with PD-L1 CPS ≥ 1, and 317 with CPS ≥ 10.
These results show that pembrolizumab plus chemotherapy, with or without bevacizumab, continued to provide clinically meaningful improvements in overall survival for patients with persistent, recurrent, or metastatic cervical cancer.— Bradley J. Monk, MD, FACS, FACOG, and colleagues
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Key Findings
At the final data cutoff in October 2022, median follow-up for the final overall survival analysis was 39.1 months (range = 32.1–46.5 months). Among all patients, median overall survival was 26.4 months (95% confidence interval [CI] = 21.3–32.5 months) in the pembrolizumab group vs 16.8 months (95% CI = 14.6–19.4 months) in the control group (HR = 0.63, 95% CI = 0.52–0.77). Rates at 12 and 24 months were 74.9% vs 63.7% and 52.1% vs 38.7%, respectively.
Among 273 vs 275 patients with CPS ≥ 1, median overall survival was 28.6 months (95% CI = 22.1–38.0 months) in the pembrolizumab group vs 16.5 months (95% CI = 14.5–20.0 months) in the control group (HR = 0.60, 95% CI = 0.49–0.74). Rates at 12 and 24 months were 75.5% vs 63.2% and 53.5% vs 39.4%, respectively.
Among 158 vs 159 patients with CPS ≥ 10, median overall survival was 29.6 months (95% CI = 20.6 months to not reached) in the pembrolizumab group vs 17.4 months (95% CI = 14.0–24.7 months) in the control group (HR = 0.58, 95% CI = 0.44–0.78). Rates at 12 and 24 months were 75.9% vs 61.6% and 54.4% vs 42.5%, respectively.
Among 35 vs 34 patients with CPS < 1, the hazard ratio for overall survival for the pembrolizumab group vs the control group was 0.87 (95% CI = 0.50–1.52). Overall, grade ≥ 3 adverse events occurred in 82.4% of the total pembrolizumab group vs 75.4% of the total control group.
The investigators concluded, “These results show that pembrolizumab plus chemotherapy, with or without bevacizumab, continued to provide clinically meaningful improvements in overall survival for patients with persistent, recurrent, or metastatic cervical cancer.”
Dr. Monk, of HonorHealth Research Institute, University of Arizona College of Medicine, Creighton University School of Medicine, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc. For full disclosures of the study authors, visit ascopubs.org.
