First-Line Pembrolizumab + Chemotherapy Versus Placebo + Chemotherapy for Persistent, Recurrent, or Metastatic Cervical Cancer: Final Overall Survival Results of KEYNOTE-826

• DOI: 10.1200/jco.23.00914
• Publication Date: 2023-11-01T19:59:13Z
• Authors: Bradley J. Monk; Nicoletta Colombo; Krishnansu S. Tewari; Coraline Dubot; M. Valeria Caceres; Kosei Hasegawa; Ronnie Shapira-Fr...; Pamela Salman; Eduardo Yañez; Mahmut Gümüş; Mivael Olivera Hu...; Vanessa Samouëlian; Vincent Castonguay; Alexander Arkhipov; Cumhur Tekin; Kan Li; Stephen M. Keefe; Domenica Lorusso
• Keywords: Clinical endpoint

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary point, may be published when key planned co-primary or secondary analyses are not yet available. Trial Updates provide an opportunity to disseminate additional results from studies, in JCO elsewhere, for which point has already been reported. phase III, double-blind KEYNOTE-826 trial of pembrolizumab 200 mg placebo once every 3 weeks up 35 cycles plus platinum-based chemotherapy, with without bevacizumab, showed statistically significant survival benefits addition patients persistent, recurrent, metastatic cervical cancer (primary data cutoff: May 3, 2021). This article reports protocol-specified final overall (OS) tested PD-L1 combined positive score (CPS) ≥1, all-comer, and CPS ≥10 populations. At cutoff (October 2022), median study follow-up duration was 39.1 months (range, 32.1-46.5 months). In ≥1 (N = 548), all-comer 617), 317) populations, OS pembrolizumab–chemotherapy versus placebo–chemotherapy 28.6 16.5 (hazard ratio [HR] death, 0.60 [95% CI, 0.49 0.74]), 26.4 16.8 (HR, 0.63 0.52 0.77]), 29.6 17.4 0.58 0.44 0.78]), respectively. incidence grade ≥3 adverse events 82.4% 75.4% placebo–chemotherapy. These show continued clinically meaningful improvements cancer.