China-based HutchMed (NASDAQ: HCM) has announced the completion of patient enrollment in its Phase II/III clinical study for Elunate (fruquintinib) in combination with Tyvyt (sintilimab) for the treatment of second-line locally advanced or metastatic renal cell carcinoma (RCC). The randomized, open-label controlled study aims to compare the efficacy and safety of the combination regimen with axitinib or everolimus alone in second-line advanced RCC, with a total of 234 patients enrolled. The primary endpoint is progression-free survival (PFS), while secondary endpoints include objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to response (TTR), overall survival (OS), safety, and quality of life.
Elunate, a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (VEGFR) 1, 2, and 3, was approved for marketing by the NMPA in September 2018 and commercially launched in China in November that year for the treatment of metastatic colorectal cancer (mCRC) in patients previously treated with fluoropyrimidine, oxaliplatin, and irinotecan, including those who previously received anti-VEGF therapy and/or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild type). The drug was included in the National Reimbursement Drug List (NRDL) in January 2020 and received a marketing nod in the United States for use in previously treated metastatic colorectal cancer last month.
Sintilimab, an innovative PD-1 inhibitor developed by Innovent Biologics (HKG: 1801), has been approved for seven indications in China and included in the NRDL for six indications.- Flcube.com
