Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive, PD-L1 (CPS) >= 1 status confers therapeutic sensitivity to Capecitabine, Oxaliplatin, Pembrolizumab, Trastuzumab in patients with Adenocarcinoma of the Gastroesophageal Junction.
The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab in combination with trastuzumab, fluoropyrimidine-, and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS >=1), as determined by an FDA-approved test. The product label notes that this indication is approved under accelerated approval based on tumor response rate and durability of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This indication is based on KEYNOTE-811 (NCT03615326), a multicenter, randomized, double-blind, placebo-controlled trial where patients received investigator's choice of chemotherapy between 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 trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test.