Shots:

• Merck is discontinuing the P-III (KEYNOTE-867) study of Keytruda + SBRT for NSCLC (stage I or II) based on DMC recommendation. Interim analysis showed no improvement in EFS or OS and the combination had a higher AE rate, incl. deaths
• Based on DMC’s recommendation, the company is also stopping the P-III (KEYNOTE-630) study of Keytruda for high-risk cSCC post-surgery & radiation. Study did not show improvement in RFS; OS was not formally evaluated, but interim data did not favor Keytruda; safety was consistent with previous findings
• Analysis of both studies is underway and data will be presented to the scientific community and regulatory agencies