EU Gives Nod to KEYTRUDA and Chemotherapy Combination Treatment

KEYTRUDA (pembrolizumab) approved for the treatment of specific lung cancer patients in combination with ALIMTA (pemetrexed) and platinum chemotherapy.

Lung cancer patients comprise one of the largest markets for oncology drugs. KEYTRUDA® (pembrolizumab) from Merck (known as MSD outside the United States and Canada) is a highly successful treatment for lung cancer. It is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating T lymphocytes that may affect both tumor cells and healthy cells.

Merck has over 750 clinical trials underway to investigate the potential of KEYTRUDA as a treatment for many different cancers. KEYTRUDA has already been approved for the treatment of melanoma, various types of lung cancer, head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma and others.

Most recently, KEYTRUDA was approved in Europe in combination with chemotherapy for first-line treatment of patients with advanced non-squamous non-small cell lung cancer, the most common form of the disease. It is the first immunotherapy to receive approval in Europe for first-line treatment (treatment of patients that have received no previous treatment) in combination with chemotherapy.

The approval is for the use of KEYTRUDA with ALIMTA® (pemetrexed) and platinum chemotherapy (cisplatin or carboplatin). This combination was approved by the US Food and Drug Administration in 2017. The European approval decision was based on the data generated in Merck’s Phase 3 KEYNOTE-189 trial, which showed first-line treatment with KEYTRUDA in combination with pemetrexed and platinum chemotherapy significantly prolonged overall survival compared to chemotherapy alone in patients with metastatic nonsquamous non-small cell lung cancer, regardless of PD-L1 expression.


Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.