Chi-Med Initiates FRESCO-2, a Global Phase III Trial of Fruquintinib in Metastatic Colorectal Cancer

HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., Sept. 04, 2020 (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) has initiated FRESCO-2, a Phase III registration study of fruquintinib for the treatment of patients with metastatic colorectal cancer (“CRC”) in the U.S., Europe and Japan. The first patient was dosed on September 3, 2020, in the U.S.

FRESCO-2 is a randomized, double-blind, placebo-controlled, multicenter trial being conducted in patients with metastatic CRC. The primary endpoint of the study is overall survival. This large phase III trial will be enrolled in approximately 130 sites in 10 countries. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04322539.

The U.S. Food and Drug Administration (“FDA”) granted Fast Track Designation for the development of fruquintinib for the treatment of patients with metastatic CRC in June 2020.  Clinical data including the completed Phase III FRESCO study in Chinese patients and this FRESCO-2 global study, if positive, would support a future New Drug Application (NDA) for the treatment of patients with advanced metastatic CRC (third-line and above), based on our agreement with the FDA. The FRESCO-2 study design was also reviewed and endorsed by the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). 

About CRC

CRC is cancer that starts in either the colon or rectum. CRC is the third most common cancer worldwide, causing more than 860,000 deaths in 2018.¹ In the U.S., it is estimated that 150,000 people will be diagnosed with CRC and 53,000 people will die from CRC in 2020.² In Europe, CRC is the second most common cancer, with an estimated 490,000 new cases and 240,000 deaths in 2018.³ In Japan, CRC is the most common cancer, with an estimated 150,000 new cases and 57,000 deaths in 2018.⁴

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (“VEGFR”) 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.