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

Merck today announced that the FDA has approved KEYTRUDA (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. In the Phase 3 KEYNOTE-859 trial, KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival compared to chemotherapy alone. The median OS was 12.9 months for KEYTRUDA plus chemotherapy versus 11.5 months for chemotherapy alone. This approval provides patients with HER2-negative gastric cancer a new first-line treatment option.