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HONG KONG - HUTCHMED (China) Limited (Nasdaq/AIM:HCM; HKEX:13) and Innovent Biologics, Inc. (HKEX: 01801) have announced positive outcomes from their FRUSICA-2 Phase II/III clinical trial. The study, which evaluated the combination of fruquintinib and sintilimab as a second-line treatment for advanced renal cell carcinoma (RCC) in China, successfully met its primary endpoint of progression free survival (PFS).
The trial, which compared the efficacy and safety of the combination therapy against monotherapies axitinib or everolimus, also showed improvements in secondary endpoints, including objective response rate (ORR) and duration of response (DoR). Detailed results are expected to be presented at an upcoming scientific conference.
The combination therapy had previously received conditional approval from the China National Medical (TASE:BLWV) Products Administration (NMPA) for advanced endometrial cancer treatment, based on the FRUSICA-1 study.
Principal Investigators Prof Dingwei Ye of Fudan University Shanghai Cancer Center and Prof Zhisong He of Peking University First Hospital highlighted the significance of the results in advancing RCC treatment options. Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED, expressed gratitude to participants and indicated plans for New Drug Application (NDA) filings in the following months.
Dr Hui Zhou, Senior Vice President of Innovent, emphasized the potential of the combination therapy to provide new hope for advanced RCC patients who have not responded to previous treatments.
Fruquintinib is an oral inhibitor of vascular endothelial growth factor receptors, playing a role in inhibiting tumor angiogenesis, and is marketed in various countries under different brand names for metastatic colorectal cancer treatment. Sintilimab is a PD-1 immunoglobulin G4 monoclonal antibody, approved in China for multiple indications, and it works by reactivating T-cells to kill cancer cells.
The FRUSICA-2 study’s findings are based on a press release statement and reflect the companies’ commitment to addressing unmet medical needs in cancer treatment. The safety and efficacy of fruquintinib for other investigational uses have not been established, and there is no guarantee of health authority approval or commercial availability for these uses.
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