Hutchison China MediTech has announced positive top-line results from FRESCO, its phase III pivotal registration trial of fruquintinib in 416 patients with locally advanced or metastatic colorectal cancer in China.
The patients had failed at least two prior chemotherapies, including fluoropyrimidine, oxaliplatin and irinotecan.
Chi-Med said the trial met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in overall survival, in the intention-to-treat (ITT) population of patients treated with fruquintinib plus best supportive care as compared to patients treated with placebo plus BSC.
Chi-Med is currently preparing to submit a new drug application for fruquintinib to the China Food and Drug Administration.
At 9:54am: (LON:HCM) Hutchison China Meditech Ltd share price was +180p at 2267.5p
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