Surufatinib Was Awarded 2 Fast Track Qualifications By The US FDA

- Mar 25, 2020-


On April 17, Hutchison China Medical Technology Co., Ltd. (Chi-Med, hereinafter referred to as Hutchison Pharma) announced that its oral tyrosine kinase inhibitor, surufatinib, was granted two Fast Track Qualifications by the US FDA (Fast Track Designations) for the treatment of advanced and progressive pancreatic neuroendocrine tumors (NET) and non-pancreatic NET patients who are not suitable for surgery. This is another important progress in the development of the drug overseas following the approval of orphan drug by FDA for the treatment of pancreatic neuroendocrine tumors (NET) in November last year.


surufatinib is a small molecule oral tyrosine kinase inhibitor, its mechanism of action is to block tumor angiogenesis by inhibiting vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR) And can inhibit the colony stimulating factor-1 receptor (CSF-1R), by regulating tumor-associated macrophages, promote the body's immune response to tumor cells. At the same time, because the drug has a dual mechanism of anti-tumor angiogenesis and immune regulation, it may be very suitable for use in combination with other immunotherapy.


Hutchison Pharmaceuticals currently owns all the rights of sovatinib worldwide. Currently, surufatinib is being used as a monotherapy or in combination with other tumor immunotherapy in China and the United States to conduct research on multiple solid tumors. According to Hutchison's press release, the current clinical studies of sofatinib in China, the United States and Europe include:


U.S. and European Neuroendocrine Tumor Research: Hutchison Pharmaceuticals plans to conduct a registered study of surufatinib in neuroendocrine tumor patients in the United States. The data of Phase 2 and Phase 3 clinical trials in China for neuroendocrine tumors as an indication for sofatinib are encouraging, and Phase 1b clinical trials in the United States are progressing smoothly.


China's non-pancreatic neuroendocrine tumor study: In 2015, Hutchison Medicine launched the SANET-ep study, which is a phase 3 clinical trial in China for the treatment of surufatinib with advanced non-pancreatic neuroendocrine tumors. In June 2019, it was announced that the interim analysis had reached the primary efficacy endpoint and the study was terminated early. On November 11, 2019, Hutchison Pharma announced that the new drug marketing application (NDA) for the treatment of advanced non-pancreatic neuroendocrine tumors by sofatinib has been accepted by the China National Drug Administration. The application is based on SANET-ep's key Phase 3 clinical research data.


The results of the study showed that sofatinib reduced the disease progression or mortality by 67% and was generally well tolerated. According to the investigator's assessment, the median PFS of patients in the surufatinib treatment group was 9.2 months, compared with 3.8 months in the placebo group. The therapeutic efficacy of sofatinib was observed in all subgroups, and these therapeutic efficacy were obtained including objective response rate (ORR), disease control rate (DCR), time to disease remission (TTR), duration of remission ( DoR) is supported by statistical data of significantly improved secondary efficacy endpoints.


China Pancreatic Neuroendocrine Tumor Study: In 2016, Hutchison Pharmaceuticals launched a key phase 3 registration study SANET-p in China. The patients included were patients with advanced pancreatic neuroendocrine tumors of low or intermediate grade. Hutchison Pharmaceutical plans to conduct a mid-term analysis in the first half of 2020 and complete patient enrollment in 2020.


China's biliary tract cancer research: In March 2019, Hutchison Medicine launched a phase 2b / 3 clinical trial to compare the efficacy and safety of surufatinib and capecitabine in the treatment of patients with advanced biliary tract cancer who failed first-line chemotherapy. The primary endpoint of this study was OS).


Immune combination therapy: In November 2018 and September 2019, Hehuang Medicine reached several cooperation agreements to evaluate the safety, tolerability, and efficacy of surufatinib combined with PD-1 monoclonal antibody. From 2018 to the present, Hutchison Pharmaceutical has reached several cooperation agreements with Cinda Biotechnology, Junshi Biotechnology and other companies to evaluate the efficacy and safety of the combination of surufatinib and PD-1 antibody.


Neuroendocrine tumors (NET) are usually divided into pancreatic neuroendocrine tumors and non-pancreatic neuroendocrine tumors. Compared with other tumors, neuroendocrine tumor patients have a relatively long survival period. Although the incidence is relatively low, the patient population is relatively large. According to an earlier Hutchison Pharmaceuticals press release, there were approximately 141,000 neuroendocrine tumor patients in the United States in 2018, of which more than nine became non-pancreatic neuroendocrine tumor patients. In China, there were approximately 67,600 newly diagnosed neuroendocrine tumors in 2018. It is estimated that there may be as many as 300,000 neuroendocrine tumor patients in China, of which approximately 80% are non-pancreatic neuroendocrine tumor patients. There is currently no effective treatment for these patients.


Fast track eligibility is one of several drug acceleration program methods used by the US FDA and can be used to expedite the development and review of potential drugs that address serious diseases and meet unmet medical needs. Projects eligible for Fast Track are eligible to interact more frequently with the US FDA on drug development programs.