Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 1% status confers therapeutic sensitivity to Cisplatin, Fluorouracil, Nivolumab in patients with Esophageal Squamous Cell Carcinoma.
The European Medicines Agency (EMA) has authorized nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable, advanced, or recurrent metastatic esophageal squamous cell carcinoma with tumor cell PD-L1 expression >= 1%. This indication is based on CA209648, a randomized, active-controlled, and open-label study where the choice of chemotherapy was fluorouracil and cisplatin.
This statement is based on a regulatory approval from the European Medicines Agency:
OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression >= 1%