Early finish in China for surufatinib
Chi-Med candidate for advanced pancreatic neuroendocrine tumors meets primary endpoint ahead of schedule
LONDON—Hutchison China MediTech Ltd. (Chi-Med), a Hong Kong-based biopharmaceutical company dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, shared some highly positive news recently on one of its eight cancer drug candidates currently in clinical studies, surufatinib, after an independent data monitoring committee (IDMC) for the Phase 3 surufatinib in advanced neuroendocrine tumors pancreatic (SANET-p) trial completed a pre-planned interim analysis.
Following that analysis, the IDMC recommended that the study be stopped early because the pre-defined primary endpoint of progression free survival (PFS) had already been met—with this early success, , Chi-Med now plans to arrange a pre-New Drug Application (NDA) meeting with the China National Medical Products Administration (NMPA) to discuss the preparation of the NDA for surufatinib for this advanced neuroendocrine tumor indication.
In November 2019, the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to surufatinib—an oral angio-immuno kinase inhibitor—for the treatment of pancreatic neuroendocrine tumors. The China NDA for surufatinib for the treatment of advanced non-pancreatic neuroendocrine tumors was accepted for review by the NMPA, and was subsequently granted Priority Review status in December. Currently Chi-Med is building an oncology-focused sales and marketing team to launch surufatinib if approved in China.
“This positive data is a further important milestone for Chi-Med,” said Christian Hogg, CEO of Chi-Med. “Following surufatinib’s NDA submission for the treatment of non-pancreatic neuroendocrine tumors, these positive results for pancreatic neuroendocrine tumors reinforce that surufatinib has the unique opportunity to address all advanced neuroendocrine tumors. We believe that no targeted therapies are approved in China or globally for such a broad spectrum of neuroendocrine tumor disease.”
The SANET-p study focused on patients with low-grade or intermediate-grade advanced pancreatic neuroendocrine tumor patients for whom there is no effective therapy. In the study, patients were randomized at a 2:1 ratio to receive either 300 mg of surufatinib orally daily or placebo, on a 28-day treatment cycle. The primary endpoint of the study is to evaluate the PFS, with secondary endpoints including objective response rate, disease control rate, time to response, duration of response, overall survival, safety and tolerability.
In other recent news, from Jan. 13, Chi-Med announced that it had initiated a Phase 2 study in China of surufatinib in combination with Tuoyi (toripalimab) in patients with advanced solid tumors. This followed the recent completion of the Phase 1 dose finding study and successful establishment of the Phase 2 combination dosing regimen for surufatinib and Tuoyi.
This China Phase 2 clinical study is part of a global collaboration with Shanghai Junshi Biosciences Co. Ltd., to evaluate surufatinib in combination with Tuoyi, Junshi’s anti-programmed cell death protein 1 monoclonal antibody which was approved by the NMPA in December 2018. The study is designed to test the potential synergistic antitumor effects of the combination’s ability to simultaneously target multiple cell types and signaling pathways in the tumor microenvironment.
Said Hogg: “We are excited to move into Phase 2 development on the surufatinib-toripalimab combination and look forward to identifying patient groups that could benefit from this innovative treatment regimen.”
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor and fibroblast growth factor receptor, which both inhibit angiogenesis, as well as colony stimulating factor-1 receptor, which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Chi-Med notes that “Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies.” Surufatinib is in several late-stage and proof-of-concept clinical trials in China and proof-of-concept clinical trials in the United States.