Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today 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®, Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults whose tumors have no EGFR or ALK genomic tumor aberrations, regardless of PD-L1 expression. If approved, this would mark the first approval in Europe for an anti-PD-1 therapy in combination with chemotherapy, and is based on overall survival (OS) and progression-free survival (PFS) data from the Phase 3 KEYNOTE-189 trial.
“There is significant need for innovative therapies that can improve the overall survival of patients suffering from metastatic non-small cell lung cancer, as lung cancer is the leading cause of cancer deaths in Europe,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “The KEYNOTE-189 trial demonstrated a significant survival benefit for the combination of KEYTRUDA with chemotherapy as compared with standard-of-care chemotherapy alone. We look forward to working with European regulatory authorities to bring this important treatment regimen to patients in Europe as quickly as possible.”
The CHMP also adopted a positive opinion recommending approval of KEYTRUDA as monotherapy for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumors express PD-L1 with a tumor proportion score (TPS) of ≥50 percent, and who progressed on or after exposure to platinum-based chemotherapy, based on data from the Phase 3 KEYNOTE-040 trial. These two recommendations will now be reviewed by the European Commission for marketing authorization in the European Union (EU). A final decision on both recommendations is expected in the third quarter of 2018.
