Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive, PD-L1 (CPS) >= 1 status confers therapeutic sensitivity to Carboplatin, Fluorouracil, Pembrolizumab, Trastuzumab in patients with Adenocarcinoma of the Gastroesophageal Junction.
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.
This statement is based on a regulatory approval from the European Medicines Agency:
KEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro -oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS >= 1.