Mar. 3, 2017
On March 3, 2017 Hutchison China MediTech Limited (“Chi-Med”) reported that it had finished its Phase III pivotal registration trial for fruquintinib with top line results. The drug was tested in 416 Chinese patients with locally advanced or metastatic colorectal cancer (“CRC”) who failed at least two prior chemotherapies, including fluoropyrimidine, oxaliplatin and irinotecan.
The trial met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in overall survival (“OS”) in patients treated with fruquintinib as compared to patients treated with a placebo. Chi-Med is currently preparing to submit a new drug application for fruquintinib to the China Food and Drug Administration.
In addition to OS, a statistically significant improvement in progression-free survival, a key secondary endpoint, was observed. The adverse events demonstrated in the trial did not identify any new or unexpected safety issues.