Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that HER2-negative and PD-L1 (CPS) >= 5 status confers therapeutic sensitivity to Fluorouracil, Nivolumab, Oxaliplatin in patients with Adenocarcinoma of the Gastroesophageal Junction.
The Republic of Ireland's Health Service Executive (HSE) has approved nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for reimbursement as a treatment option for the first-line treatment of adult patients with HER-2 negative advanced or metastatic gastric (GC), gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC), whose tumours express PD-L1 (CPS) >= 5. This regimen specifically cites FOLFOX-6 modified therapy as the chemotherapy. It also notes that, as the platinum and fluoropyrimidine based chemotherapy is not defined in the EMA licensed indication, other evidence-based platinum and fluoropyrimidine regimens may be used in combination with nivolumab.
This statement is based on a regulatory approval from the Health Service Executive:
Nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER-2 negative advanced or metastatic gastric (GC), gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC), whose tumours express PD-L1 (CPS) >= 5.