Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-negative status confers therapeutic sensitivity to Capecitabine, Oxaliplatin, Pembrolizumab in patients with Adenocarcinoma of the Gastroesophageal Junction.
The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. This indication is based on KEYNOTE-859 (NCT03675737), a multicenter, randomized, double-blind, placebo-controlled trial where patients received investigator's choice of combination chemotherapy of either cisplatin and 5-fu or oxaliplatin and capecitabine.
This statement is based on a regulatory approval from the Food and Drug Administration:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.