The supplemental Biologics License Application ( sBLA ) for anti-PD-1 therapy, Keytruda ( Pembrolizumab ), for the treatment of patients with advanced non-small cell lung cancer ( NSCLC ) whose disease has progressed on or after Platinum-containing chemotherapy, and a therapy for EGFR or ALK genomic tumor aberrations, if present.
The sBLA submission was based in part on data from KEYNOTE-001, including patients with greater than or equal to 50% of tumor cells positive for PD-L1 expression, which were presented at the 2015 American Association for Cancer Research ( AACR ) Annual Meeting.
These data also served as the basis for the FDA Breakthrough Therapy designation for Keytruda in advanced non-small cell lung cancer.
Keytruda monotherapy is administered at a dose of 2 mg/kg every three weeks, which is the currently approved dose for advanced melanoma.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, Pembrolizumab releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
Lung cancer 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 NSCLC and SCLC.
NSCLC is the most common type of lung cancer, accounting for about 85% of all cases.
The five-year relative survival rate for patients suffering from highly advanced, metastatic ( stage IV ) lung cancers is estimated to be 4%. ( Xagena )
Source: Merck, 2015