The global healthcare company Hutchison China MediTech Limited (Chi-Med), has announced that its R&D subsidiary Hutchison MediPharma Limited (HMP) is beginning FALUCA, a Phase 3 registration clinical trial of fruquintinib (HMPL-013) as a third-line treatment for patients with non-squamous non-small cell lung cancer (NSCLC) across China.
Fruquintinib (HMPL-013) is a novel small molecule compound that selectively inhibits vascular endothelial growth factor receptors (VEGFRs), a protein ligand that at advanced stages is secreted in large amounts to stimulate the formation of novel vasculature (angiogenesis) within the tumor microenvironment, increasing blood flow, oxygen, and nutrients to the tumor. In low oral doses, fruquintinib has potent inhibitory effects on multiple human tumor xenografts, including some refractory tumors such as pancreatic cancer and melanoma.
FALUCA is a Phase 3, multicenter, randomized, double-blind, placebo-controlled registration trial for advanced NSCLC patients who have failed two lines of systemic chemotherapy. All study participants will be randomly assigned to receive fruquintinib (5mg orally once per day) in cycles of three weeks of treatment followed by one week of rest plus best supportive care (BSC), or cycles of BSC and placebo.
The trial’s primary outcome is overall survival (OS) and secondary outcomes include progression-free survival (PFS), objective response rate (ORR), disease control rate, and duration of response. The company is aiming to enroll 520 patients across 45 sites in China. Top-line data is expected in 2017.
Last September, the company announced that a Phase 2 proof-of-concept study of fruquintinib in patients with third-line non-squamous NSCLC in China had reached the primary endpoint of PFS. There were no unexpected safety issues. Complete data of this Phase II trial will be presented in 2016 at a global scientific meeting.
Non-small-cell lung carcinoma is any type of epithelial lung cancer other than small-cell lung carcinoma (SCLC), and accounts for about 85% to 90% of all lung cancers. As a class, NSCLCs is relatively insensitive to chemotherapy compared to small cell carcinoma. When possible, this malignancy is primarily treated by surgical resection with curative intent, although chemotherapy is increasingly being used both pre-operatively (neoadjuvant chemotherapy) and post-operatively (adjuvant chemotherapy).