EC clears pembrolizumab combo for mNSCLC

May 8, 2019 0 By FM

Pembrolizumab (Keytruda), an anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, has been approved by EC for the first-line treatment of adults with metastatic squamous non-small cell lung cancer (NSCLC), Merck announced.

This approval is based on data from the phase 3 KEYNOTE-407 trial, which demonstrated that pembrolizumab 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 percent compared to chemotherapy alone.

In NSCLC, pembrolizumab 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.

Pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel significantly improved OS, reducing the risk of death by 36 percent compared to chemotherapy alone.

Pembrolizumab is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. The humanized monoclonal antibody blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells.