Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that PD-L1 >= 1% status confers therapeutic sensitivity to Fluorouracil, Nivolumab, Oxaliplatin in patients with Esophageal Squamous Cell Carcinoma.
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 unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma with tumor cell programmed death ligand 1 (PD-L1) expression >= 1%. This regimen specifically cites cisplatin and 5-fluorouracil 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 unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell programmed death ligand 1 (PD-L1) expression >= 1%.