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Find Clinical Drug Pipeline Developments & Deals for Surufatinib
Hutchmed will initiate a clinical advancement of their lead product Sulanda (surufatinib) in combination with camrelizumab for the treatment of naïve pancreatic ductal adenocarcinoma.
Safety and efficacy of HMPL-012 (surufatinib), an oral inhibitor of angiogenesis and immune modulation, was demonstrated in SANET-p and SANET-ep studies, in patients with advanced pNETs and epNETs conducted in China.
SURTORI-01, a Phase III study to evaluate the efficacy and safety of surufatinib (SULANDA), a novel, oral angio-immuno kinase inhibitor in combination with toripalimab compared with FOLFIRI to treat patients with advanced neuroendocrine carcinoma.
Surufatinib received fast track designation in April 2020 for the treatment of pancreatic and extra-pancreatic NET. Orphan Drug Designation for pancreatic NET was also granted in November 2019.
This trial is to explore potential synergistic activity of the novel, oral angio-immuno kinase inhibitor surufatinib with the anti-PD-1 antibody tislelizumab in enhancing overall antitumor activity from inhibition of angiogenesis along with stimulation of an immune response.
The NMPA approval of Sulanda® was based on results from the SANET-ep study. The Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS in all subgroups of non-pancreatic NET patients with an acceptable risk/benefit ratio.
The pivotal Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS of non-pancreatic NET patients with an acceptable risk/benefit ratio.
Phase III SANET-p demonstrated surufatinib reduces the risk of disease progression or death by 51% in patients with pancreatic neuroendocrine tumors (“NET”).
The NDA is supported by data from the successful SANET-p study, a Phase III pivotal study of surufatinib in advanced neuroendocrine tumors – pancreatic patients in China for whom there is no effective therapy.