Biopharmaceutical company Hutchison China MediTech (Chi-Med) has reported top-line results from its Phase III pivotal registration trial (FRESCO) of fruquintinib (HMPL-013) in 416 patients with locally advanced or metastatic colorectal cancer (CRC) in China.
Fruquintinib is a highly selective, small-molecule drug candidate that has been shown to inhibit VEGFR 24 hours a day via an oral dose.
The randomised, double-blind, placebo-controlled, multicentre trial met its primary endpoint of demonstrating a rise in overall survival (OS), in the intention-to-treat (ITT) population of patients treated with fruquintinib plus best supportive care (BSC).
An improvement in progression-free survival (PFS), a key secondary endpoint, was also observed.
Hutchison China MediTech chairman Simon To said: “The success of the FRESCO trial is an important milestone not just for CRC patients and Chi-Med, but also for Chinese innovation.
“It shows that China has the resources, capability and perseverance to emerge as an innovator in the global oncology field. With eight small molecule drug candidates in more than 30 clinical studies worldwide, Chi-Med is at the forefront of this important evolution.”
In addition to the FRESCO colorectal cancer trial, fruquintinib is being studied in China in a Phase III pivotal trial in non-small-cell lung cancer (NSCLC), known as FALUCA.
The company is also planning other studies and will initiate them soon.
They include a Phase III trial in gastric cancer along with paclitaxel in China, new studies in the US, and other exploratory studies in combination with oncology agents.
About 380,000 new cases of CRC are reported in China every year, according to CA Cancer Journal for Clinicians 2016.