Chi-Med to Discuss Select Global Clinical Trial Data Presented at ASCO20 - Seite 3

Savolitinib patients had not reached median OS at data cut-off, compared to 13.2 months for sunitinib patients (hazard ratio [“HR”] 0.51; 95% CI: 0.21–1.17; p=0.110).  Median PFS was 7.0 months for savolitinib patients, compared to 5.6 for sunitinib patients (HR 0.71; 95% CI 0.37–1.36; p=0.313). 

Responses were observed in 27% and 7% of savolitinib and sunitinib patients, respectively. This difference did not reach statistical significance due to the small sample size. None of the 9 responders on savolitinib treatment experienced disease progression as of data cut-off, compared to 1 of 2 responders on sunitinib treatment.  Sunitinib response rate was in range with previous studies.^2,3 

Grade ≥3 AEs were reported in 42% of savolitinib patients versus 81% of sunitinib patients, with AEs leading to dose modification in 30% and 74% of savolitinib and sunitinib patients, respectively. 

Surufatinib, an oral selective inhibitor of vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), and colony stimulating factor-1 receptor (CSF-1R)

In clinical studies to date, involving over 900 patients, surufatinib has demonstrated robust efficacy and safety profile, including in two randomized, double-blind, placebo controlled, multi-center Phase III studies in pancreatic neuroendocrine tumor (“pNET”) and non-pancreatic (extra-pancreatic) neuroendocrine tumor patients (“epNET”).  In the U.S. surufatinib was granted Fast Track Designations for development in pNET and epNET, and Orphan Drug Designation for pancreatic NET.  In China a New Drug Application (“NDA”) is under review and a second is in preparation.

Presentation Title:	Efficacy and safety of surufatinib in U.S. patients with neuroendocrine tumors (“NET”)
Authors:	A Dasari, D Li, MW Sung, C Tucci, JS Kauh, MK Kania, AS Paulson
Abstract Link:	4610

Preliminary data from the two NET cohorts in the ongoing US Phase Ib trial for surufatinib demonstrated promising efficacy irrespective of prior lines of therapy, with a manageable safety profile comparable with the larger pool of surufatinib safety data (NCT02549937).