Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, at a dose of 2 mg/kg every three weeks, for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients 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 approved therapy for these mutations prior to receiving KEYTRUDA. The EC approval allows marketing of KEYTRUDA in all 28 EU member states.
The approval is based on findings from KEYNOTE-010, a pivotal study which showed KEYTRUDA significantly improved overall survival (OS) compared to standard of care chemotherapy.
“This approval provides an important new treatment regimen for patients in Europe with advanced lung cancer, one of the most common and challenging cancers,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “In the KEYNOTE-010 trial, patients with advanced lung cancer who had failed prior regimens experienced improved overall survival when treated with KEYTRUDA as compared with those treated with traditional chemotherapy.”
“The survival benefit for KEYTRUDA observed in previously-treated patients who express PD-L1 is promising,” said Dr. Luis Paz-Ares, chair of the medical oncology department, Hospital Universitario, Madrid, Spain. “There is a significant unmet need for lung cancer patients, and with this approval, we now have a new personalized treatment option which uses biomarker testing to predict which patients are most likely to benefit from treatment.”