Roche's PD-1/LAG-3 Bispecific Antibody RO7247669 Granted Clinical Trial Approval in China for Hepatocellular Carcinoma

By | Pharma Insights

According to a public notice from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), Roche's application for the Class 1 new drug RO7247669 injection has received implied approval for a clinical trial, intended for the treatment of liver cancer. Publicly available information indicates that RO7247669 is a bispecific antibody targeting PD-1 and LAG-3, with Phase 1/2 clinical trials currently underway globally. This marks the first clinical trial approval for the drug in China.

Screenshot source: CDE official website

A bispecific antibody is an antibody capable of specifically binding to two distinct antigens. This therapy harnesses T cells from the patient's immune system to kill tumors. One arm binds to an antigen on the surface of cancer cells, while the other arm binds to the T cell receptor on the surface of T cells, thereby recruiting T cells to the vicinity of cancer cells and activating T cell-mediated cytotoxicity against cancer cells.

RO7247669 is a bispecific antibody targeting PD-1 and LAG-3 developed by Roche. The PD-1/PD-L1 immune checkpoint is a prominent target in the field of cancer immunotherapy and is widely recognized. Meanwhile, LAG-3 has also emerged as one of the leading frontier targets in the field, with the development of LAG-3-targeting antibodies achieving significant progress this year.

LAG-3 stands for Lymphocyte-Activation Gene 3. It is an immune checkpoint protein expressed on the surface of effector T cells and regulatory T cells (Tregs), capable of modulating signaling pathways in T lymphocytes and antigen-presenting cells (APCs), and plays a crucial role in adaptive immune responses. LAG-3 and PD-1 mediate distinct signaling pathways, but they may exert synergistic effects, leading to the exhaustion of effector T cells.

According to public information on ClinicalTrials.gov, Roche is conducting multiple clinical trials to evaluate the safety and efficacy of RO7247669 across indications including metastatic melanoma, non-small cell lung cancer, esophageal squamous cell carcinoma, and advanced hepatocellular carcinoma. According to the CDE website, this marks the first clinical trial approval for RO7247669 in China, with development intended for the treatment of liver cancer.

References:

[1] Center for Drug Evaluation (CDE), National Medical Products Administration. Retrieved Sep 09, 2021, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=25

[2] ClinicalTrials.gov website. From https://clinicaltrials.gov/ct2/results?cond=&term=RO7247669&cntry=&state=&city=&dist=

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