Hutchison China MediTech Limited (“Chi-Med”) has announced that it has completed patient enrollment of FRESCO, its Phase III pivotal trial of fruquintinib (HMPL-013) in third-line locally advanced or metastatic colorectal cancer (“CRC”) in China, where an estimated 390,000 new cases of CRC were diagnosed in 2012.
Fruquintinib is a highly selective small molecule drug candidate that has been shown to inhibit vascular endothelial growth factor receptors (VEGFR) 24 hours a day via an oral dose, without known off-target toxicities. The FRESCO trial is evaluating the efficacy of fruquintinib versus placebo, with all patients receiving best supportive care (“BSC”). The primary endpoint is overall survival (“OS”).
“Completing enrollment of our first Phase III clinical trial is an important milestone for our company,” said Christian Hogg, Chief Executive Officer of Chi-Med. “We believe fruquintinib has the potential to significantly improve outcomes in several types of solid tumors. While we wait for the FRESCO CRC data to mature over the balance of the year, we are focused on accelerating the ongoing Phase III FALUCA pivotal trial in non-small cell lung cancer (“NSCLC”), and launching additional studies of fruquintinib, including a Phase II study in gastric cancer in combination with paclitaxel, new studies in the U.S., and certain exploratory studies in combination with other oncology agents.”
The FRESCO trial was launched following a 71-patient, randomized, double-blind Phase II trial of fruquintinib as a third-line treatment for metastatic CRC. The study met its primary endpoint of progression free survival (“PFS”) of 4.73 months for patients receiving fruquintinib versus 0.99 month for the placebo arm, with a hazard ratio of 0.30 (p<0.001), and had no unexpected safety issues. The positive data resulted in a US$18 million payment to Chi-Med from its partner, Eli Lilly and Company (“Lilly”).