Posted by Michael Wonder on 10 Sep 2018
European Commission approves Merck’s Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations
10 September 2018 - European approval based on results from pivotal Phase 3 trial KEYNOTE-189 demonstrating Keytruda in combination with pemetrexed and platinum chemotherapy significantly improved overall survival and progression-free survival compared with chemotherapy alone.
Merck today announced that the European Commission has approved Keytruda, the company’s anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults whose tumours have no EGFR or ALK positive mutations.
This approval, the first in Europe for an anti-PD-1 therapy in combination with chemotherapy, is based on data from the pivotal Phase 3 KEYNOTE-189 trial in patients with metastatic non-squamous NSCLC regardless of PD-L1 tumour expression status, which demonstrated a significant survival benefit for the combination of Keytruda with chemotherapy as compared with standard-of-care chemotherapy alone – reducing the risk of death in these patients by half (HR=0.49 [95% CI, 0.38-0.64]; p<0.00001).
