Hutchison China MediTech's (Chi-Med's) research and development subsidiary Hutchison MediPharma has reported positive top-line results from its second proof-of-concept (POC) trial of fruquintinib in patients with advanced non-squamous non-small cell lung cancer (NSCLC) in China.
The results showed that the trial clearly succeeded in meeting the primary efficacy endpoint of progression free survival (PFS).
In this randomised, double-blind, placebo-controlled, multi-centre, POC Phase II trial a total of 91 patients were randomised to receive fruquintinib plus BSC or placebo plus BSC at a 2:1 ratio.
Fruquintinib has been developed to selectively inhibit vascular endothelial growth factor (VEGF) receptors, namely VEGFR1, VEGFR2 and VEGFR3.
The trial designed for NSCLC patients who have failed second-line chemotherapy was started in June 2014 and completed patient enrolment in March this year.
The company noted that the evaluation of secondary efficacy endpoints, including objective response rate, disease control rate, and overall survival is ongoing, while all appearing in-line with expectations at the August 2015 five-month data cut-off.
In this POC trial, the adverse events showed are consistent with the known safety profile for fruquintinib without major unexpected safety issues.
The company noted that this is the second POC Phase II trial for fruquintinib aimed at comparing the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with NSCLC as a third-line therapy.
The first POC Phase II trial for fruquintinib, targeted at patients with metastatic third-line colorectal cancer, clearly met its primary endpoint of superior median PFS versus placebo in March 2015.
Detailed results from the first POC trial will be presented at the upcoming 2015 European Cancer Congress later this month.
China-based Chi-Med researches, develops, manufactures, and sells pharmaceuticals and health-related consumer products.