16 November 2023 - Today, the FDA approved pembrolizumab (Keytruda, Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction adenocarcinoma.
Efficacy was evaluated in KEYNOTE-859, a multi-centre, randomised, double-blind, placebo-controlled trial that enrolled 1579 patients with HER2 negative advanced gastric or gastro-oesophageal junction adenocarcinoma who had not previously received systemic therapy for metastatic disease.