China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced the results of the pivotal global Phase III FRESCO-2 study for its VEGFR 1/2/3 inhibitor Elunate (fruquintinib) in advanced refractory metastatic colorectal cancer (CRC) at the European Society for Medical Oncology (ESMO) 2022 annual meeting.
Study Design and Results
The multi-center study evaluated the efficacy and safety of Elunate combined with best supportive care (BSC) compared to placebo/BSC in patients with metastatic CRC. The trial recruited 691 patients across sites in the US, Europe, Japan, and Australia (NCT04322539). Results showed that Elunate achieved a statistically and clinically significant prolongation in overall survival (OS: 7.4 months vs 4.8 months) and progression-free survival (PFS: 3.7 months vs 1.8 months). The drug also significantly improved the disease control rate (DCR: 55.5% vs 16.1%).
Safety Profile
The safety profile of Elunate was consistent with previous studies in Chinese populations. Adverse events of grade 3 or higher occurred in 62.7% of patients receiving Elunate, compared to 50.4% of patients receiving placebo. The most common adverse events of grade 3 or higher were hypertension, fatigue, and hand-foot syndrome.
Background and Commercialization
Elunate, a vascular endothelial growth factor receptor (VEGFR) 1/2/3 inhibitor, 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 collaborating with Eli Lilly & Co. on the commercialization of Elunate in China, while retaining all rights outside the country.-Fineline Info & Tech
