Approval is based on the Phase 3 KEYNOTE-811 Trial

KIRKLAND, QC, Feb. 12, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of  KEYTRUDA^® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours express PD-L1 (Combined Positive Score [CPS] ≥ 1) as determined by a validated test. This approval is based on the results from the Phase 3 KEYNOTE-811 trial, which demonstrated a statistically significant improvement in progression-free survival (PFS) compared to placebo in combination with trastuzumab and chemotherapy in the intention-to-treat (ITT) study population.