Keytruda for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression with no EGFR or ALK positive tumor mutations, recommended by CHMP for approval
The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, for the first-line treatment of metastatic non-small cell lung cancer ( NSCLC ) in adults whose tumors have high PD-L1 expression ( tumor proportion score [ TPS ] of 50% or more ) with no EGFR or ALK positive tumor mutations.
Keytruda is currently approved in Europe for the second-line treatment of patients with locally advanced or metastatic NSCLC whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen.
Patients with EGFR or ALK positive tumor mutations should also have received targeted therapy before receiving Keytruda.
The positive opinion is based on data from KEYNOTE-024, a pivotal study which demonstrated superior overall survival and progression-free survival with Pembrolizumab compared to chemotherapy in patients whose tumors expressed high levels of PD-L1 with no EGFR or ALK positive tumor mutations.
KEYNOTE-024 was a randomized, open-label, phase 3 study evaluating Pembrolizumb monotherapy at a fixed dose of 200 mg compared to standard of care Platinum-containing chemotherapy for the treatment of patients with both squamous and non-squamous metastatic NSCLC.
The study enrolled patients who had not received prior systemic chemotherapy treatment for their metastatic disease and whose tumors had high PD-L1 expression with no EGFR or ALK aberrations.
Pembrolizumab is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.
Pembrolizumab blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Keytruda is administered as an intravenous infusion over 30 minutes every three weeks for the approved indications. Keytruda for injection is supplied in a 100 mg single use vial.
Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide.
Each year, more people die of lung cancer than die of colon, breast, and prostate cancers combined.
The two main types of lung cancer are non-small cell and small cell.
NSCLC is the most common type of lung cancer, accounting for about 85% of all cases.
The five-year survival rate for patients suffering from highly advanced, metastatic ( stage IV ) lung cancers is estimated to be 2%. ( Xagena )
Source: Merck, 2016