During ESMO 2023, the results of the ENGOT-cx11/GOG-3047/KEYNOTE-A18 trial were presented. This trial marked the first evaluation of Pembrolizumab immunotherapy in combination with chemoradiation for locally advanced high-risk cervical cancer since 1999. Historically, the treatment for such patients involved concomitant chemoradiation followed by brachytherapy. However, this trial aimed to demonstrate an improvement in progression-free and overall survival when combining immunotherapy with chemoradiation.
A total of 160 patients were enrolled and randomized into two groups: one receiving concomitant chemoradiation followed by brachytherapy with a placebo, and the other receiving the same treatment with Pembrolizumab. The trial had two primary endpoints: progression-free survival and overall survival.
The final results for progression-free survival showed a significant improvement in patients treated with Pembrolizumab, with a 30% reduction in the risk of progression. Although the data for overall survival was not yet mature, there was a positive trend with a 73% reduction in risk. Notably, the combination therapy's toxicity profile was favorable, with minimal differences in grade 3-4 adverse events between the two groups, and only one patient in the Pembrolizumab group discontinued treatment due to unrelated side effects. Furthermore, the quality of life of the patients, as evaluated using the drtc ql qc30, remained unaffected, with no significant differences between the two treatment arms.
In conclusion, the ENGOT-cx11/GOG-3047/KEYNOTE-A18 trial is poised to impact clinical practice by demonstrating a 30% reduction in the risk of progression in locally advanced high-risk cervical cancer patients. While awaiting the final results for overall survival, these findings are of great clinical significance and could change the standard of care for this patient population.