Merck discontinuesd phase III trial of Keytruda (pembrolizumab)for the adjuvant treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma

The DMC recommended that the study should be stopped for futility as the risk/benefit profile did not support continuing the trial. Data from a pre-planned analysis showed that Keyruda did not cross the boundary for statistical significance in recurrence-free survival (RFS), the study’s primary endpoint. The study’s key secondary endpoint, OS, was not formally tested, but at the time of the analysis, the results did not favor Keytruda compared to placebo. The safety profile of Keytruda in this trial was consistent with the established safety profile of Keytruda.

About KEYNOTE-630: KEYNOTE-630 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT03833167 ) evaluating Keytruda as adjuvant therapy in patients with high-risk locally advanced cSCC who have undergone surgery with or without positive margins and completed adjuvant radiotherapy compared to placebo. The primary endpoint is RFS, and key secondary endpoints include OS and safety. The trial enrolled an estimated 430 patients who were randomized to receive either: Keytruda (400 mg intravenously [IV] every six weeks [Q6W] for up to nine cycles) as adjuvant therapy following surgery and radiation; or Placebo (IV Q6W for up to nine cycles) as adjuvant therapy following surgery and radiation.