Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that the US Food and Drug Administration (FDA) has accepted for review the Biologic License Application (BLA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, combined with the small-molecule targeted cancer therapy apatinib, as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC).
Phase III Clinical Study Results
The filing is supported by the SHR-1210-III-310 study, a global, multi-center Phase III clinical trial that demonstrated significant survival benefits and a tolerable safety profile for the combination therapy, with a median overall survival (OS) of 22.1 months. This study is recognized as the first and currently only successful Phase III study for the combination of an immunotherapy and a small molecule tyrosine kinase inhibitor (TKI) in HCC.
Camrelizumab and Apatinib Background
Camrelizumab was first approved in China in May 2019 and has since received nine indication approvals, including for liver cancer, lung cancer, esophageal squamous cell carcinoma (ESCC), nasopharyngeal cancer (NPC), and lymphoma. Apatinib, a selective vascular endothelial growth factor receptor-2 (VEGFR-2) TKI, was initially approved in 2014 for advanced gastric cancer/Gastroesophageal junction cancer (GC/GEJ) that has progressed or relapsed after at least two systemic chemotherapies. It was later approved for use in advanced hepatocellular carcinoma in patients unresponsive to or intolerable of first-line or later systemic therapies in January 2021 and for first-line treatment of HCC combined with camrelizumab in January of this year.-Fineline Info & Tech
