Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PD-L1 (CPS) >= 10 status confers therapeutic sensitivity to Cisplatin, Fluorouracil, Pembrolizumab in patients with Esophageal Adenocarcinoma.

The European Medicines Agency (EMA) has authorized pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy as a first-line treatment for adult patients with locally advanced unresectable or metastatic esophageal carcinoma whose tumors express PD-L1 with a combined positive score (CPS) >= 10. This indication is based on KEYNOTE-590, randomised, double-blind, placebo-controlled trial of 749 patients in which cisplatin and fluorouracil was evaluated with and without pembrolizumab.

This statement is based on a regulatory approval from the European Medicines Agency:

KEYTRUDA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD-L1 with a CPS >= 10.

Citation

Merck Sharp & Dohme B.V. Keytruda (pembrolizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf. Revised January 2024. Accessed March 10, 2024.

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2021-06-24	European Medicines Agency	Indication received approval from the European Commission.