Merck's KEYTRUDA Significantly Improves Survival Vs Chemotherapy In NSCLC

(RTTNews) - Merck (MRK), known as MSD outside the United States and Canada, announced that Phase 2/3 study, KEYTRUDA (pembrolizumab), Merck's anti-PD-1 (programmed death receptor-1) therapy, significantly improved overall survival compared to chemotherapy in patients with any level of PD-L1 expression, as defined by a tumor proportion score of 1 percent or more. The results were published in The Lancet and will be presented at the European Society for Medical Oncology Asia 2015 Congress.

The company announced results from the pivotal KEYNOTE-010 study to evaluate the potential of an immunotherapy compared to chemotherapy based on prospective measurement of PD-L1 expression in patients with advanced non-small cell lung cancer or NSCLC.

Merck plans to submit supplemental Biologics License Application to FDA for KEYTRUDA based on findings from KEYNOTE-010 by the end of 2015. The company plans to submit a Marketing Authorization Application to the European Medicines Agency in early 2016.