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