Recently, Merck & Co., Inc. (Merck) announced that its PD-1 inhibitor, pembrolizumab, has been approved by the National Medical Products Administration (NMPA) of China for use in combination with lenvatinib and transarterial chemoembolization (TACE) for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma.
The approval of this new indication is based on data from the Phase III LEAP-012 clinical trial. In this multicenter, randomized, double-blind, Phase III study (LEAP-012), 480 patients were enrolled and randomly assigned to receive either lenvatinib plus TACE plus pembrolizumab (n=237) or TACE plus dual placebo (n=243).
The results showed that the median progression-free survival (PFS) was 14.6 months in the lenvatinib plus TACE plus pembrolizumab group, compared to 10.0 months in the placebo group. The 24-month overall survival (OS) rates were 75% and 69%, respectively.
Lenvatinib is a kinase inhibitor used to treat certain types of cancer. Kinase inhibitors are enzyme inhibitors that blocks the action of one or more protein kinases.
Pembrolizumab is a humanized monoclonal IgG4 kappa antibody directed against human cell surface PD-1 (programmed death receptor-1) on lymphocytes. The PD-1 receptor provides an important “immune checkpoint,” which helps prevent the immune system from attacking itself. Certain types of tumors have a high expression of PD-L1(programmed death receptor ligand-1). Other tumor types use adaptive immune resistance where they take the natural physiology of PD-L1 induction (protection of immune-mediated damage from infections) and adapt it towards anti-tumor responses. When PD-L1 engages with PD-1, the T-cell function becomes inhibited; pembrolizumab blocks the PD-1: PDL-1 complex formation allowing improved T-cell mediated killing.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
Email：myimmnet@163.com
Post time: Jun-19-2025