Therapeutic Response

HER2-positive and PD-L1 (CPS) >= 1 status confers therapeutic sensitivity to Cisplatin in combination with Fluorouracil, Pembrolizumab, and Trastuzumab in patients with Adenocarcinoma of the Gastroesophageal Junction.

Statements

Source and description
Keytruda (pembrolizumab) [package insert]. FDA. The U.S. Food and Drug Administration granted 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. 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.
Keytruda (pembrolizumab) [product information]. EMA. The European Medicines Agency (EMA) has authorized 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 gastro-esophageal junction adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS) >= 1.