Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company based in China, has announced a new attempt at a market filing with the US Food and Drug Administration (FDA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, in combination with the small-molecule targeted cancer therapy apatinib, as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC). This follows an initial Biologic License Application (BLA) for the combination, which was accepted for review in August 2023 but did not receive approval.
The latest filing is supported by the positive results of the global, multi-center Phase III CARES-310 study. Updated data from the study have demonstrated significant survival benefits and a tolerable safety profile for the camrelizumab and apatinib combination in the first-line treatment of advanced HCC. Notably, the treatment achieved a median overall survival (mOS) of 23.8 months, marking the longest median OS data obtained in the first-line treatment of HCC to date. This combination therapy was previously approved for the treatment of first-line unresectable or metastatic HCC in China last year, based on the results of the CARES-310 study.- Flcube.com
