Chi-Med Highlights Surufatinib Phase III Results in Neuroendocrine Tumors at ESMO 2020 and Publications in The Lancet Oncology - Seite 2

The safety profile of surufatinib was manageable and consistent with observations in prior studies. Treatment was well tolerated for most patients, with discontinuation rates as a result of treatment emergent adverse events of 10.6% in the surufatinib group as compared to 6.8% in the placebo group.

In the U.S., the Food and Drug Administration (“FDA”) granted surufatinib two Fast Track Designations, for both the non-pancreatic NET and pancreatic NET development programs, and Orphan Drug Designation for pancreatic NET development. A rolling new drug application (“NDA”) submission is being prepared, to be followed by a marketing authorization application (“MAA”) submission to the European Medicines Agency (“EMA”) in Europe, based on the robust data from the two studies and the ongoing multi-cohort Phase Ib study in the U.S. In December 2019, an NDA for surufatinib for the treatment of patients with advanced non-pancreatic NET was granted Priority Review status by the China National Medical Products Administration (“NMPA”). A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET has also been accepted by the NMPA.

About NET

NET form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. NET are typically classified as pancreatic NET or non-pancreatic NET. Approved targeted therapies include Sutent and Afinitor for pancreatic NET, or well-differentiated, non-functional gastrointestinal or lung NET.

According to Frost and Sullivan, there were 19,000 newly diagnosed cases of NET in the U.S. in 2018. Importantly, NET are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 141,000 estimated patients living with NET in the U.S. in 2018.

In China, there were approximately 67,600 newly diagnosed NET patients in 2018 and, considering the current incidence to prevalence ratio in China, potentially as many as 300,000 patients living with the disease in the country.³  

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.