30 July 2018 - KEYTRUDA combination improved overall survival compared with pemetrexed and platinum chemotherapy alone in pivotal Phase 3 trial (KEYNOTE-189).

Merck announced today that the CHMP of the 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 non-squamous non-small cell lung cancer (NSCLC) in adults whose tumours have no EGFR or ALK genomic tumour 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 and progression-free survival data from the Phase 3 KEYNOTE-189 trial.

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 of ≥50%, 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 authorisation in the European Union. A final decision on both recommendations is expected in the third quarter of 2018.

Read Merck press release