MSD’s Keytruda may become the first anti-PD-1 drug in Europe to be approved in combination with chemotherapy, following a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP).
The committee has recommended Keytruda in combination with Alimta (pemetrexed) and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of metastatic nonsquamous NSCLC lung cancer in adults whose tumors have no EGFR or ALK genomic tumor aberrations, regardless of PD-L1 expression.
The approval 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 Perlmutter, president of MSD Research Laboratories.
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 tumours express PD-L1 with a tumour proportion score (TPS) of ≥50 percent, and who progressed on or after exposure to platinum-based chemotherapy.
These two recommendations will now be reviewed by the European Commission for marketing authorisation in the EU. A final decision on both recommendations is expected in the third quarter of 2018.