Merck has announced that 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), the company’s anti-PD-1 therapy, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. The CHMP positive opinion for KEYTRUDA will now be reviewed by the European Commission for marketing authorization in the European Union (EU).
“This news marks an important step in making KEYTRUDA available for appropriate patients suffering from locally advanced or metastatic non-small cell lung cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We are grateful to patients and investigators around the world who participated in these studies and who are helping to advance this important new treatment.”
Data supporting the CHMP positive opinion were based on findings from two studies, KEYNOTE-010, a pivotal study assessing overall survival (OS) and KEYNOTE-001, which assessed overall response rates (ORR).
The CHMP recommended approval of KEYTRUDA monotherapy at a dose of 2 mg/kg every three weeks, which is also the FDA-approved dose for metastatic NSCLC in the United States. Based on this recommendation, a final decision regarding the approval of KEYTRUDA (pembrolizumab) monotherapy is expected from the European Commission in the third-quarter of 2016.
KEYNOTE-010 is an open-label, randomized phase 2/3 trial assessing OS with two doses of KEYTRUDA (2 mg/kg or 10 mg/kg every three weeks) compared to docetaxel (75 mg/m2 every three weeks), a standard of care chemotherapy, in patients with any level of PD-L1 expression (as defined by a tumor proportion score [TPS] of 1 percent or more). KEYNOTE-001 is a multicenter, open-label multi-cohort, activity-estimating study evaluating ORR of KEYTRUDA (2 mg/kg or 10 mg/kg every three weeks).