FDA approves Merck’s Keytruda plus chemotherapy as first-line treatment

Merck announced that the U.S. Food and Drug Administration has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma. The approval is based on data from the Phase 3 KEYNOTE-859 trial, in which KEYTRUDA plus chemotherapy reduced the risk of death by 22% compared to chemotherapy alone for these patients. Median overall survival was 12.9 months for KEYTRUDA plus chemotherapy versus 11.5 months for chemotherapy alone.