Therapeutic Response

PD-L1 >= 1% status confers therapeutic sensitivity to Pembrolizumab in patients with Non-Small Cell Lung Cancer.

Statements

Source and description
Keytruda (pembrolizumab) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to pembrolizumab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 [Tumor Proportion Score (TPS) >=1%], as determined by an FDA-approved test, with disease progression on or after platinum containing chemotherapy. The product label further states that patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
Keytruda (pembrolizumab) [product information]. EMA. The European Medicines Agency (EMA) has authorized pembrolizumab as a monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung carcinoma whose tumors express PD-L1 with a >= 1% tumor proportion score (TPS) and who have recieved at least one prior chemotherapy regime. Patients with EGFR or ALK positive tumor mutations should also have received targeted therapy before receiving pembrolizumab.