FDA approves Keytruda (pembrolizumab) + chemotherapy as first-line treatment for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma
Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA 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 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma
The approval is based on data from the Phase III KEYNOTE-859 trial, in which Keytruda plus chemotherapy reduced the risk of death by 22% (HR=0.78 [95% CI, 0.70?0.87]; p<0.0001) compared to chemotherapy alone for these patients. median overall survival (os) was 12.9 months (95% ci, 11.9-14.0) for keytruda plus chemotherapy versus 11.5 months (95% ci, 10.6-12.1) for chemotherapy alone.
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