Hutchison China Meditech Limited

Sulfatinib Phase II Study in 2nd Line BTC in China - Seite 2

[1] A Ananthakrishnan et al; Epidemiology of Primary and Secondary Liver Cancers; Semin Intervent Radiol. 2006 Mar; 23(1): 47-63.
[2] JA Bridgewater et al; Biliary Tract Cancer: Epidemiology, Radiotherapy, and Molecular Profiling; Am Soc Clin Oncol Educ Book. 2016;35:e194-203.

About Sulfatinib
Sulfatinib is an oral, novel angio-immunokinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR, FGFR and CSF-1R, three key tyrosine kinase receptors involved in tumor angiogenesis and immune evasion. Inhibition of the VEGFR signaling pathway can act to stop angiogenesis, the growth of the vasculature around the tumor, and thereby starve the tumor of the nutrients and oxygen it needs to grow rapidly. Aberrant activation of the FGFR signaling pathway, which can be increased by anti-VEGFR therapy treatment, is shown to be associated with cancer progression by promoting tumor growth, angiogenesis and formation of the myeloid derived suppressor cells. Inhibition of the CSF-1R signaling pathway blocks the activation of tumor-associated macrophages, which are involved in suppressing immune responses against tumors.

In addition to the BTC trial, six sulfatinib clinical trials are underway in China and the United States, including two Phase III studies in neuroendocrine tumor patients (SANET-p and SANET-ep) and a Phase II study in thyroid cancer patients.

The SANET-p trial is a randomized, double-blind, placebo-controlled, multi-center, Phase III pivotal registration trial to treat about 190 pathologically low or intermediate grade pancreatic NET patients in China whose disease has progressed, locally advanced or distant metastasized and for whom there is no effective therapy. The primary endpoint is PFS, with secondary endpoints including ORR, DCR, duration of response, time to response and OS. Additional details of the SANET-p study may be found at clinicaltrials.gov, using identifier NCT02589821. The SANET-ep trial is similar to the SANET-p trial and is targeted at treating about 270 non-pancreatic NET patients in China. Additional details of the SANET-ep study may be found at clinicaltrials.gov, using identifier NCT02588170.