Merck recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approving Keytruda (pembrolizumab) for locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with PD-L1 expressing tumors.
Next, the European Commission could approve marketing authorization in the European Union (EU) by the end of the year; dosage will likely be 2 mg/kg every three weeks as it was approved by the US FDA.
CHMP’s recommendation is based on data from the clinical studies KEYNOTE-010, which examined overall NSCLC survival; and KEYNOTE-001, a clinical study for responses to treatment.
“This news marks an important step in making Keytruda available for appropriate patients suffering from locally advanced or metastatic non-small cell lung cancer,” said Merck’s Dr. Roger Dansey, senior vice president and therapeutic area head of oncology late-stage development, in a press release. “We are grateful to patients and investigators around the world who participated in these studies and who are helping to advance this important new treatment”
Lung cancer is the most common cause of cancer death worldwide, with NSCLC making up approximately 85 percent of all lung cancers. There is only a 2 percent five-year relative survival rate for individuals who have highly advanced, metastatic (stage 4) lung cancer.
Keytruda is a monoclonal antibody that increases the immune system’s ability to combat tumor cells. It blocks a protein called PD-1 (programmed cell death protein 1) and associated proteins PD-L1 and PD-L2, and activates important immune cells known as T lymphocytes.
The therapy is approved by the FDA for the treatment of inoperable or metastatic melanoma, and for metastatic NSCLC with PD-L1 expressing tumors.
The recent trial KEYNOTE-024 determined that the Keytruda is superior to first-line chemotherapy for promoting survival in NSCLC with high levels of PD-L1; which led to the trial’s discontinuation and the drug being made available to control group patients.
“We believe that the KEYNOTE-024 results have the potential to change the therapeutic paradigm in first-line treatment of non-small-cell lung cancer,” said Dr. Roger M. Perlmutter, president of Merck Research Laboratories. “We look forward to sharing these data with the medical community and with regulatory authorities around the world.”