London: Tuesday, 8 December 2015: Hutchison China MediTech Limited ("Chi‑Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has initiated FALUCA, a Phase III registration study for fruquintinib (HMPL‑013) in third-line non-squamous non-small cell lung cancer ("NSCLC") patients in China. Fruquintinib is an investigational small molecule which selectively inhibits vascular endothelial growth factor receptors ("VEGFR"). Preparations and site selection began in August this year, with the first patient dosed on 8 December 2015.
FALUCA is a randomised, double-blind, placebo-controlled, multi-centre, Phase III registration study targeted at treating patients with advanced non-squamous NSCLC, who have failed two lines of systemic chemotherapy. Patients will be randomised at a 2:1 ratio to receive either 5mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus best supportive care ("BSC"); or placebo plus BSC. The primary endpoint is overall survival, with secondary endpoints including progression free survival, objective response rate, disease control rate and duration of response. HMP plans to enrol approximately 520 patients in about 45 centres across China, with top-line results expected in 2017.
In September this year, Chi-Med announced that the Phase II proof-of-concept ("POC") trial of fruquintinib in patients with third-line non-squamous NSCLC in China had successfully achieved the primary endpoint of progression free survival ("PFS") with no unexpected safety issues. The detailed results of this Phase II study will be presented in a global scientific conference in 2016.