Merck Submits SBLA For KEYTRUDA In Advanced Non-Small Cell Lung Cancer

(RTTNews) - Merck (MRK) announced the company has submitted a supplemental Biologics License Application to the U.S. FDA for KEYTRUDA (pembrolizumab), the company's anti-PD-1 therapy, for the treatment of advanced non-small cell lung cancer. KEYTRUDA previously received Breakthrough Therapy designation for advanced NSCLC and this initial filing seeks approval in the treatment of patients with advanced NSCLC whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present.

The submission is based on data from KEYNOTE-001 in patients with greater than or equal to 50 percent of tumor cells positive for PD-L1 expression.

Roger Perlmutter, president, Merck Research Laboratories, said: "In this study, NSCLC patients whose tumors express PD-L1 in the majority of their cells experienced the highest response rates to KEYTRUDA treatment. The results from this study formed the basis for our Breakthrough Therapy designation and our recent FDA submission for advanced NSCLC, and indicate that tumor PD-L1 expression may be a relevant biomarker to identify patients more likely to have higher rates of response to KEYTRUDA in this tumor type."