Merck Receives FDA Approval for Keytruda in HER2-Positive Gastric Cancer

Merck today announced that the FDA has approved KEYTRUDA (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. In the Phase 3 KEYNOTE-811 trial, the combination demonstrated a statistically significant improvement in overall survival compared to trastuzumab plus chemotherapy. The median OS was 20.0 months for KEYTRUDA plus trastuzumab and chemotherapy versus 16.8 months for trastuzumab and chemotherapy. This approval provides a new first-line treatment option for HER2-positive gastric cancer.