Merck To Discontinue Phase 3 Keynote-867 Trial Of Keytruda Plus Stereotactic Body Radiotherapy For Patients With Stage I Or II Non-small Cell Lung Cancer And Phase 3 Keynote-630 Trial Of Keytruda As Adjuvant Treatment Of Patients With High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma Following Surgery And Radiation

. This decision is based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis. At the pre-specified interim analysis, KEYTRUDA in combination with SBRT did not demonstrate an improvement in event-free survival (EFS) or overall survival (OS), the study's primary endpoint and key secondary endpoint, respectively, compared to placebo plus SBRT, and the benefit/risk profile of the combination did not support continuing the trial. KEYTRUDA in combination with SBRT was associated with higher rates of adverse events (AEs), including AEs leading to death, compared with SBRT and placebo.

Merck is also discontinuing the Phase 3 KEYNOTE-630 trial evaluating KEYTRUDA for the adjuvant treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) following surgery and radiation, based on the recommendation of an independent DMC. 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 KEYTRUDA 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.