European Commission approves Keytruda + trastuzumab + chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 . _ Merck Inc.,
Merck Inc., known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] greater than 1).
This approval by the EC follows the positive recommendation from the Committee for Medicinal Products for Human Use received in July 2023 and was based on results from the Phase III KEYNOTE-811 trial. In the study, Keytruda plus trastuzumab and chemotherapy significantly improved progression-free survival (PFS), and objective response rate (ORR), compared to trastuzumab and chemotherapy alone in this patient population. In the study, more than 80% of patients had tumors that were PD-L1 positive.
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