Abstract
At the second interim analysis, the ENGOT-cx11/GOG-3047/KEYNOTE-A18 demonstrated an overall survival (OS) benefit after 36 months in stage III–IVa cervical cancer patients treated with chemoradiotherapy and concurrent pembrolizumab followed by 90 weeks of pembrolizumab as compared to placebo (82.6% vs. 74.8%, hazard ratio for death, 0.67 [confidence interval, 0.50–0.90]). Only 51 of 193 progressing patients in the control arm were exposed to immunotherapy after progressing. The reported OS benefit could be explained by suboptimal post-progression treatment in the control group. Even if pembrolizumab as administered in the ENGOT-cx11/GOG-3047/KEYNOTE-A18 was efficacious, the treatment duration is excessively long. The associated costs render it unattainable in the regions where burden of cervical cancer is highest. Based on these concerns, the findings at the interim analysis of the ENGOT-cx11/GOG-3047/KEYNOTE-A18 RCT should not change practice.