European regulators have approved Merck’s Keytruda in combination with chemotherapy as a first-line treatment for adults with metastatic squamous non-small cell lung cancer (NSCLC).
The approval is based on data from the Phase 3 KEYNOTE-407 trial which demonstrated that Keytruda in combination with chemotherapy significantly improved overall survival (OS) in adults with metastatic squamous NSCLC regardless of PD-L1 tumour expression status, reducing the risk of death by 36% compared to chemotherapy alone.
The approval allows marketing of the Keytruda combination in all 28 EU member states plus Iceland, Lichtenstein and Norway.
In the NSCLC indication, Keytruda is also approved in Europe for the first-line treatment of metastatic nonsquamous NSCLC in combination with pemetrexed and platinum chemotherapy in adults whose tumours have no EGFR or ALK positive mutations (KEYNOTE-189).
It is also approved as a first-line treatment of metastatic squamous or nonsquamous NSCLC as monotherapy in adults whose tumors have high PD-L1 expression with no EGFR or ALK positive tumour mutations; and as a treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 and who have received at least one prior chemotherapy regimen.