Clinical Trials

The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival in this indication, with the drug’s safety profile remaining consistent with previously observed safety information and no new safety signals being identified.

It is expected that the full results will be presented at an upcoming medical meeting as well as being shared with the relevant global regulatory authorities.

Dr Gursel Aktan, vice president, global clinical development at Merck Research Laboratories, commented: “This is the first phase 3 trial in which an immunotherapy-based regimen has shown a statistically significant and clinically meaningful improvement in overall survival compared to chemoradiotherapy alone. Building on the positive progression-free survival findings from this study, these results underscore our commitment to exploring the role of Keytruda across different types of cancers in earlier stages of disease, where there is a greater potential for better outcomes.”

Professor Domenica Lorusso, the study’s overall principal investigator, lead investigator for ENGOT, and professor of Obstetrics and Gynecology at Humanitas University, Italy, added: “These findings are important for patients and the medical community alike and reinforce previous data from the KEYNOTE-A18 trial, now showing this regimen has the potential to extend the lives of patients with locally advanced cervical cancer.”