Hutchmed has reported that the registrational Phase III FRESCO-2 clinical trial of fruquintinib met the primary endpoint of overall survival (OS) in advanced, refractory metastatic colorectal cancer (CRC) patients.

The international, multi-regional trial was carried out in the US, Europe, Japan and Australia.

It analysed fruquintinib in combination with best supportive care (BSC) compared with placebo plus BSC in trial subjects. 

These metastatic CRC patients were selected as they should have progressed following standard chemotherapy and relevant biologic agents as well as progressed on, or were not tolerant to, TAS-102 and/or regorafenib. 

Findings showed that treatment with fruquintinib offered a statistically significant improvement in progression-free survival (PFS), a vital secondary endpoint of the trial. 

Furthermore, fruquintinib’s safety profile in this trial was in line with priorly reported data from trials. 

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The company is in talks with regulatory authorities across the globe on the FRESCO-2 trial design and conduct. 

It will also discuss these findings with the authorities in the US, Japan and Europe to seek marketing authorisation soon. 

In June 2020, the US Food and Drug Administration (FDA) granted fast track designation to develop fruquintinib for treating metastatic CRC. 

An oral VEGFR-1, -2 and -3 inhibitor, fruquintinib is said to boost kinase selectivity to reduce off-target toxicities, increase tolerability and offer steady target coverage.

Hutchmed International executive vice-president, managing director and chief medical officer Dr Marek Kania said: “We are very happy to see the positive outcomes of the FRESCO-2 study which offers a potential new treatment for patients with advanced metastatic colorectal cancer, where the unmet need is very high and patients have limited treatment options. 

“Results from the global FRESCO-2 study supplement findings from the original FRESCO study that led to the marketing approval and commercialisation of fruquintinib in China.”

Last week, the company dosed the first subject in a bridging study of tazemetostat for relapsed/refractory follicular lymphoma in China.