Pembrolizumab in combo with pemetrexedOctober 10, 2018
The European Commission has approved pembrolizumab (Keytruda), Merck’s anti-PD-1 therapy, in combination with pemetrexed (Alimta) and platinum chemotherapy for the first-line treatment of metastatic nonsquamous 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 nonsquamous NSCLC regardless of PD-L1 tumour expression status. The data 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, the company said.
The approval allows marketing of the Keytruda combination in all 28 EU member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every three weeks until disease progression or unacceptable toxicity.
Keytruda is also approved in Europe as a monotherapy for the first-line treatment of metastatic squamous or nonsquamous NSCLC in patients whose tumours have high PD-L1 expression with
no EGFR or ALK positive tumour mutations and for previously-treated patients with locally advanced or metastatic NSCLC whose tumours express PD-L1.