Merck has announced that it has received approval from the Chinese National Medical Products Administration (NMPA) in China for Keytruda (pembrolizumab) for treating patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC), whose tumors express PD-L1. The drug is indicated as a second-line treatment.
The approval is based on the Phase 3 KEYNOTE-181 trial, which evaluated the overall survival of Keytruda. The drug was compared with chemotherapy in patients who were previously treated with recurrent or metastatic ESCC whose tumors expressed PD-L1. The median overall survival was 12 months in patients who were on Keytruda versus 5.4 months in patients who were on chemotherapy.
Keytruda has been approved for five different indications across three different cancers in China and is the first PD-1 inhibitor approved for esophageal cancer.
Esophageal cancer is the seventh most common cancer in the world, can be either squamous cell carcinoma or adenocarcinomas. 90% of the esophageal cancers in china are squamous cell carcinomas. In China, esophageal cancer is the fifth most common cancer and is the fourth leading cancer that causes death.
Keytruda is a human monoclonal antibody that inhibits PD-1 interaction and its ligands. This activates lymphocytes, which affect tumor cells and healthy cells.