Hutchmed China's colorectal cancer study to be published

16th Jun 2023 08:44

(Sharecast News) - Hutchmed China, alongside its partner Takeda, announced the publication of the phase three 'FRESCO-2' study results evaluating the use of fruquintinib in patients with previously-treated metastatic colorectal cancer (CRC) on Friday, in the Lancet medical journal.

The AIM-traded firm said the study demonstrated significant improvements in overall survival and progression-free survival among participants.

It described fruquintinib as a highly selective and potent inhibitor of vascular endothelial growth factor receptors -1, -2, and -3.

The global phase three multi-regional clinical trial, known as FRESCO-2, was conducted in the United States, Europe, Japan, and Australia.

It compared fruquintinib plus best supportive care (BSC) with placebo plus BSC in patients with previously-treated metastatic CRC.

The FRESCO-2 study met its primary and key secondary endpoints, demonstrating that treatment with fruquintinib led to a statistically-significant and clinically-meaningful improvement in both overall survival and progression-free survival compared to the placebo group.

Moreover, the safety profile of fruquintinib in the study was consistent with previous fruquintinib studies.

"FRESCO-2 was a key study supporting regulatory submissions to the US Food and Drug Administration for fruquintinib for the treatment of previously-treated metastatic CRC, which was accepted for review and granted priority review in May," the Hutchmed board explained in its statement.

"Filing of a marketing authorisation application to the European Medicines Agency and a new drug application to the Japan Pharmaceuticals and Medical Devices Agency are planned in 2023.

"In March, Hutchmed and Takeda closed an exclusive licence agreement to further the global development, commercialisation and manufacture of fruquintinib outside of China."

At 0829 BST, shares in Hutchmed China were up 2.42% at 212p.

Reporting by Josh White for Sharecast.com.