HUTCHMED and Innovent Jointly Announce that the FRUSICA-2 Phase II/III Study of Fruquintinib and Sintilimab Combination Has Met its Primary Endpoint in Advanced Renal Cell Carcinoma in China

Core Insights - The FRUSICA-2 Phase II/III clinical trial has successfully met its primary endpoint of progression-free survival (PFS) for the combination of fruquintinib and sintilimab in treating advanced renal cell carcinoma (RCC) in China [1][3] - The combination therapy has shown improvements in secondary endpoints, including objective response rate (ORR) and duration of response (DoR), indicating its potential as a new treatment option for patients who have not responded adequately to previous therapies [3][4] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on the discovery and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [18] - Innovent Biologics is a leading biopharmaceutical company dedicated to developing affordable, high-quality medicines for various diseases, including cancer [19] Clinical Trial Details - The FRUSICA-2 study is a randomized, open-label trial comparing the efficacy and safety of fruquintinib and sintilimab against axitinib or everolimus monotherapy for second-line treatment of advanced RCC [3] - Full results from the FRUSICA-2 study will be presented at an upcoming scientific conference, highlighting the significance of the findings [3] Market Context - In 2022, approximately 435,000 new kidney cancer cases were diagnosed globally, with around 74,000 cases in China, where RCC accounts for about 90% of kidney tumors [5] - The combination of fruquintinib and sintilimab has received conditional approval for treating advanced endometrial cancer, showcasing the companies' commitment to addressing unmet medical needs in oncology [2][9] Product Information - Fruquintinib is a selective oral inhibitor targeting all three vascular endothelial growth factor (VEGF) receptors, playing a crucial role in inhibiting tumor angiogenesis [6][7] - Sintilimab, marketed as TYVYT, is a PD-1 monoclonal antibody that reactivates T-cells to combat cancer cells, with multiple indications approved in China [14][15]