China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) has announced the initial results from the FRUTIGA Phase III study, which evaluated Elunate (fruquintinib) combined with paclitaxel in 703 Chinese patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ). The study aimed to assess the efficacy and safety of fruquintinib in combination with paclitaxel compared to paclitaxel monotherapy for second-line treatment.
Study Results
The randomized, double-blind Phase III study achieved a statistically and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS). Although the other primary endpoint of overall survival (OS) did not meet the pre-specified statistical target, there was an improvement in median OS. Fruquintinib also demonstrated statistically significant improvements in secondary endpoints, including objective response rate (ORR), disease control rate (DCR), and duration of response (DoR). The safety profile of fruquintinib in the FRUTIGA study was consistent with previously reported studies.
Elunate Profile
Elunate is a vascular endothelial growth factor receptor (VEGFR) 1/2/3 inhibitor that received its first market approval in China in September 2018 for third-line treatment of colorectal cancer (CRC). The drug was added to the National Reimbursement Drug List (NRDL) at the beginning of 2020. HutchMed is partnering with Eli Lilly & Co. for the commercialization of Elunate in China, while retaining all rights outside the country.-Fineline Info & Tech
