An In-Depth Analysis of Surufatinib (DB15106): A Novel Angio-Immuno Kinase Inhibitor for Neuroendocrine Tumors

Executive Summary

Surufatinib is a novel, orally administered small-molecule drug developed by HUTCHMED for the treatment of solid tumors. It is distinguished by a unique dual mechanism of action as an "angio-immuno" kinase inhibitor, concurrently targeting pathways involved in tumor angiogenesis and the immune-suppressive tumor microenvironment. Specifically, it potently inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3, and fibroblast growth factor receptor 1 (FGFR1) to block the formation of new blood vessels, while also inhibiting colony-stimulating factor-1 receptor (CSF-1R) to modulate the activity of tumor-promoting macrophages.

The clinical value of surufatinib has been robustly demonstrated in two pivotal, randomized, placebo-controlled Phase III trials conducted in China. The SANET-ep trial showed that surufatinib significantly improved median progression-free survival (PFS) to 9.2 months versus 3.8 months for placebo in patients with advanced extra-pancreatic neuroendocrine tumors (epNETs). Similarly, the SANET-p trial demonstrated a median PFS of 10.9 months versus 3.7 months for placebo in patients with advanced pancreatic neuroendocrine tumors (pNETs). These compelling results, which led to both trials being stopped early for efficacy, formed the basis for surufatinib's approval in China under the brand name Sulanda®, where it is now an important treatment option for patients with NETs.