March 3, 2017
By Alex Keown, BioSpace.com Breaking News Staff
HONG KONG – Shares of Hutchison China Meditech Limited are up slightly this morning after that company announced its Phase III trial fruquintinib as a third line treatment in patients with locally advanced or metastatic colorectal cancer met all primary and secondary endpoints.
Hutchison China Meditech, better known as Chi-Med, is backed by billionaire Li Ka-shing. The company was founded in 2000. According to a company release this morning, fruquintinib demonstrated a statistically significant increase in overall survival in the intention-to-treat (ITT) population of patients treated with fruquintinib plus best supportive care compared to placebo. Not only did fruquintinib demonstrate an increase in overall survivability, the drug also showed a statistically significant improvement in progression free survival. How significant the company did not say. Chi-Med said it intends to release full data details on the trial at an upcoming scientific meeting in mid-2017.
Colorectal cancer is the second most common cancer type in China, with about 380,000 new cases per year, the company said. There were approximately 1.5 million new CRC cases globally in 2015 which are expected to increase to approximately 1.7 million new cases per year by 2020, Chi-Med said. No drugs have been approved in third-line CRC in
Fruquintinib (HMPL-013) 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. The drug works by shutting down capillary growth between the veins and tumors. VEGF receptors play a pivotal role in tumor-related angiogenesis. Fruquintinib can be used in combination with chemotherapy and other targeted treatments like immunotherapy, Bloomberg reported this morning.
Chi-Med said it is preparing to submit a new drug application for fruquintinib to the China Food and Drug Administration.
“Well over a decade of effort and investment has now paid-off with these compelling Phase III top-line results. They reinforce fruquintinib’s potential to address major unmet clinical needs for patients in both China and around the world. They also open the way to our submitting a NDA on fruquintinib around the middle of this year,” Simon To, Chi-Med’s chairman of the board said in a statement.
In addition to metastatic colorectal cancer, fruquintinib is also in clinical development for the treatment of gastric cancer and lung cancer. The drug is in a Phase III trial in non-small cell lung cancer. It’s also in a Phase II trial as a combination treatment with Iressa, a protein kinase inhibitor developed by AstraZeneca , in the first-line setting for patients with advanced or metastatic NSCLC.
