Two new studies demonstrating the potential of Merck’s Keytruda (pembrolizumab) as a first-line treatment for metastatic non-small cell lung cancer will be presented at the European Society for Medical Oncology (ESMO) 2016 in Denmark.
The injectable drug is a humanized monoclonal antibody that amps up the body’s immune system so that it can detect and fight tumor cells by blocking a protein called PD-1.
The first study, known as KEYNOTE-024, evaluated 305 patients who were previously untreated and whose tumors expressed high levels of PD-L1. The findings were published in The New England Journal of Medicine.
About half of participants were randomly assigned to receive a 200 mg dose of Keytruda every three weeks, while the other half received four to six cycles of chemotherapy. Those taking the immuno-oncology medicine saw a 50 percent reduction in the risk of disease progression or death and a 40 percent reduction in risk of death compared to platinum-based chemotherapy regimens, the current standard of care, according to the company.
Two of the most common side effects were diarrhea, and fatigue. According to the release there was one treatment related death in a patient receiving Keytruda, but the cause was unknown.
“These data from KEYNOTE-024 demonstrate the potential of Keytruda to change the way non-small cell lung cancer is currently treated,” lead author Dr. Martin Reck, head of the thoracic oncology department at the LugenClinic in Germany said in a statement. “This provides additional evidence that testing for PD-L1 levels should become standard in lung cancer at first diagnosis to guide treatment decisions.”
The second study, known as KEYNOTE-021, was published in The Lancet Oncology, and enrolled 123 patients regardless of PD-L1 expression of their tumors. Findings show that Keytruda, in combination with chemotherapy, works better than chemotherapy alone, and reduced the risk of disease progression or death by 47 percent.
The U.S. Food and Drug Administration had previously granted the drug Breakthrough Therapy Designation and approved it for treatment of patients with advanced non-small cell lung cancer who had already undergone chemotherapy.