Takeda (TYO: 4502) and HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) have announced that the results of the Phase III FRESCO-2 study for Elunate (fruquintinib) in previously treated metastatic colorectal cancer (mCRC) have been published in The Lancet journal. The global Phase III study, conducted across the US, Europe, Japan, and Australia, assessed the efficacy of fruquintinib in combination with best supportive care (BSC) compared to placebo plus BSC in previously treated mCRC patients.
FRESCO-2 Study Achieves Primary and Secondary Endpoints
The FRESCO-2 study successfully achieved both its primary and key secondary endpoints, demonstrating that fruquintinib led to statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS). Notably, fruquintinib reduced the risk of death in treated mCRC patients by 34% (0.66 HR). The safety profile of the drug was consistent with previous clinical trials, further validating its potential as a treatment option.
Supporting Regulatory Filings in US, Europe, and Japan
The positive data from the FRESCO-2 study is bolstering regulatory filings for Elunate in the US, Europe, and Japan. HutchMed has announced that the market filing for fruquintinib in previously treated mCRC has been accepted for review by the European Medicine Agency, with an anticipated market filing in Japan within the year. Previously, the US has also accepted the market filing for the drug for review.
Elunate: A Potent Inhibitor of VEGFR for mCRC
Elunate is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (VEGFR) 1, 2, and 3. It was approved for marketing by the NMPA in September 2018 and was commercially launched in China in November of the same year for the treatment of mCRC in patients who had previously been treated with fluoropyrimidine, oxaliplatin, and irinotecan. This includes patients who had received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Elunate was included in the National Reimbursement Drug List (NRDL) in January 2020. In March 2023, Takeda Pharma secured a USD 1.13 billion licensing deal for the development, manufacturing, and development rights of Elunate globally, excluding mainland China, Hong Kong, and Macau. Eli Lilly holds exclusive commercialization rights to the drug in China.-Fineline Info & Tech
