Approval is based on the Phase 3 KEYNOTE-859 Trial

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA(R) (pembrolizumab),Merck'santi-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing-chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. This approval is based on the results from the Phase 3 KEYNOTE-859 trial, which demonstrated a statistically significant improvement in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to placebo in combination with chemotherapy in the intention-to-treat (ITT) study population.