Merck : FDA Approves Merck's KEYTRUDA (pembrolizumab) Combined With Trastuzumab and Chemotherapy as First-line Treatment in Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

KENILWORTH, N.J. - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck's anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This indication is approved under accelerated approval based on tumor response rate and durability of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This approval is based on data from the ongoing Phase 3 KEYNOTE-811 trial, in which KEYTRUDA in combination with trastuzumab and either 5-fluorouracil plus cisplatin or capecitabine plus oxaliplatin demonstrated a statistically significant objective response rate (ORR) of 74% (95% CI, 66-82) for patients who received the regimen with KEYTRUDA versus 52% (95% CI, 43-61) for those who received trastuzumab and chemotherapy alone (p

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