HQ Team
September 19, 2024: Merck & Co’s combination drug, Keytruda, which treats advanced lung cancer, has been approved by the US drug regulator, the Food and Drug Administration.
The drug in combination with chemotherapy was approved based on results from an end-stage trial in which it showed “statistically significant improvement in overall survival versus chemotherapy alone,” according to a company statement.
The approval “marks the first indication for Keytruda in malignant pleural mesothelioma in the US.”
Merck’s anti-PD-1 therapy is an immunotherapy that uses monoclonal antibodies to block the programmed cell death 1 (PD-1) protein on T cells, which identify and kill abnormal cells.
‘Prognoses generally poor’
PD-1 is a protein that acts as a “brake” on T cells, preventing them from attacking other cells in the body. When PD-1 is blocked, T cells can kill cancer cells more effectively.
According to the France-based non-profit foundation Servier Laboratories, the immunotherapy treats advanced solid tumours and different types of cancer such as malignant pleural mesothelioma.
Merck’s therapy is a first-line treatment option for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma, “a disease where prognoses are generally poor,” said Dr Gregory Lubiniecki, vice president, of oncology clinical research, Merck Research Laboratories.
“This milestone underscores our commitment to advancing research for patients with difficult-to-treat tumours,”
The end-stage trial enrolled 440 patients with unresectable advanced or metastatic and no prior systemic therapy for advanced metastatic disease, regardless of tumour PD-L1 expression. The patients were observed for 24 months for disease progression.
“The trial demonstrated a statistically significant improvement in overall survival, progression free survival, and objective response rate in patients randomized to Keytruda in combination with chemotherapy compared with patients randomized to chemotherapy alone,” according to the statement.
Lining of the lungs
Malignant mesothelioma is a type of cancer that starts in the lining of certain parts of the body, including the chest, abdomen, heart and testicles.
Worldwide, it is estimated there were more than 30,000 new cases of mesothelioma diagnosed and more than 25,000 deaths from the disease in 2022.
Pleural mesothelioma, which develops in the lining of the lungs, is the most common form of malignant mesothelioma, accounting for about 75% of all cases.
Malignant pleural mesothelioma can progress rapidly, and the five-year survival rate for all stages of cases diagnosed in the US from 2014-2020 was 12.8%.
As of now, more than 1,600 trials are studying Keytruda across cancers and treatment settings.
