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 Stomach Adenocarcinoma.
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.