By Fineline Cube China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced that the pivotal global Phase III FRESCO-2 study for its VEGFR 1/2/3 inhibitor Elunate (fruquintinib) in advanced refractory metastatic colorectal cancer (CRC) has met the primary overall survival (OS) endpoint. The multi-center study, initiated in July 2020, recruited 691 patients across sites in the US, Europe, Japan, and Australia to support global regulatory filings (NCT04322539). The trial assessed Elunate combined with best supportive care (BSC) compared with placebo/BSC in patients with metastatic CRC who have disease progression on, or were intolerant to, chemotherapy, biologics, and TAS-102 or regorafenib.
Study Results
In addition to the improvement in overall survival, Elunate also demonstrated significant benefits in progression-free survival (PFS), a key secondary endpoint. The drug’s safety profile was consistent with previous studies in Chinese populations.
Drug Background
Elunate is a vascular endothelial growth factor receptor (VEGFR) 1/2/3 inhibitor that received its first market approval in China in September 2018 as a third-line treatment for CRC. The drug was added to the National Reimbursement Drug List (NRDL) from the beginning of 2020. HutchMed is partnered with Eli Lilly & Co. for the commercialization of the product in China, while retaining all rights outside the country.
Future Plans
During HutchMed’s recent Q2 2022 earnings conference call, it was noted that a positive readout from FRESCO-2 would be followed by a rolling, fast-track application with the US FDA later this year. CSO Dr. Su Weiguo highlighted that the trial is expected to fully comply with the US FDA’s requirements for full MRCT data reflecting the US patient population.-Fineline Info & Tech