Merck Says Health Canada Oks KEYTRUDA In Combination With Trastuzumab And Chemotherapy

(RTTNews) - Merck & Co., Inc. (MRK), known as MSD outside the U.S. and Canada, announced Monday 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 tumors express PD-L1 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.