Merck has secured approval from the European Commission for its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with pemetrexed (ALIMTA) and platinum chemotherapy to treat a type of metastatic nonsquamous non-small cell lung cancer (NSCLC).
Keytruda is the first anti-PD-1 therapy approved in combination with chemotherapy in Europe for first-line use in patients with metastatic NSCLC.
The European approval is for the first-line treatment of NSCLC in adults whose tumors have no EGFR or ALK positive mutations.
The approval allows the pharma giant to market the Keytruda combination therapy across all 28 European Union member states and also in Iceland, Lichtenstein and Norway.
The approved dosage strength is 200mg, which is to be given every three weeks until disease progression or unacceptable toxicity.
Merck Oncology president Frank Clyburn said: “Lung cancer is the leading cause of cancer death in Europe, and we are committed to doing everything in our power to help address it.
“Today Keytruda is now approved across Europe for the treatment of appropriate patients with metastatic nonsquamous non-small cell lung cancer as both a monotherapy and in combination with chemotherapy.”
According to Merck, the approval for the Keytruda combination is based on the findings of the phase 3 trial called Keynote-189, which was held in patients with metastatic nonsquamous NSCLC irrespective of PD-L1 tumor expression status.
The trial showed a significant survival benefit for the combination of Keytruda with chemotherapy in comparison to standard-of-care chemotherapy alone, by bringing down the risk of death in the patients by half.
Merck Research Laboratories president Roger Perlmutter said: “We are very pleased that the European Commission has approved Keytruda in combination with chemotherapy based on the significant survival benefit demonstrated in the Keynote-189 trial.
“This approval is a first in Europe and adds to the rapidly growing role of Keytruda as a foundation for the treatment of lung cancer.”
Keytruda functions by enhancing the ability of the body’s immune system to help identify and fight tumor cells. The humanized monoclonal antibody prevents the interaction between PD-1 and its ligands, PD-L1 and PD-L2 in order to activate T lymphocytes which may affect tumor cells and also healthy cells.
Earlier this month, Keytruda was given priority review designation by the US Food and Drug Administration (FDA) for the treatment of Merkel cell carcinoma, a rare type of skin cancer, caused by a Merkel cell associated polyomavirus.