Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that CD274 amplification, Wild type ALK, and Wild type EGFR status confers therapeutic sensitivity to Pembrolizumab in patients with Non-Small Cell Lung Cancer.

The European Medicines Agency (EMA) has authorized pembrolizumab as a monotherapy for the first-line treatment of metastatic non-small cell lung carcinoma in adult patients whose tumors express PD-L1 with a >= 50% tumor proportion score (TPS) with no EGFR or ALK positive tumor mutations.

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

KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a >= 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.

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.