Merck and Co., Inc. (MRK), globally recognized as MSD, announced on Monday that Health Canada has given its approval for the use of KEYTRUDA (pembrolizumab), which is Merck's anti-PD-1 therapy. The therapy will be used in combination with trastuzumab, as well as fluoropyrimidine and platinum-based chemotherapy. This approved treatment is designed for initial treatment of adult patients suffering from locally advanced non-removable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma. The effectiveness for this type of treatment will apply to the tumors that express PD-L1, as validated by a specific test.
The approval from Health Canada is realized on the conclusion of the Phase 3 KEYNOTE-811 trial. The trial highlighted a statistically significant advancement in progression-free survival (PFS) in comparison to a placebo combined with trastuzumab and chemotherapy in the context of the intention-to-treat study population.
