"The surufatinib phase-1, phase-2, and SANET-p studies all demonstrated antitumor activity in heavily pretreated patients, including those failed on sunitinib and everolimus," Dr. Jianming Xu of The Fifth Medical Center, Chinese PLA General Hospital, in Beijing, told Reuters Health by email. "Surufatinib would provide clinically meaningful benefit for these patients with refractory diseases."
Surufatinib is a small-molecule inhibitor that simultaneously targets tumor angiogenesis and immune invasion. In a separate phase-3 study, surufatinib significantly improved PFS in patients with NETs originating outside the pancreas.
In the current study, Dr. Xu and colleagues from 21 hospitals across China assessed the safety and efficacy of surufatinib in a double-blind, placebo-controlled study of 172 patients with advanced pancreatic NETs, most of whom had received previous systemic antitumor drugs and had liver metastases and three or more organs involved.
After a median follow-up of 19.3 months in the surufatinib group and 11.1 months in the placebo group, median PFS as assessed by the investigators was significantly longer with surufatinib (10.9 months) than with placebo (3.7 months), the researchers report in The Lancet Oncology.
Results were similar in the assessment of the blinded independent image-review committee assessed PFS (13.9 months with surufatinib vs. 4.6 months with placebo).
Based on the significant improvement of PFS with surufatinib, the study was terminated after the interim analysis on recommendation from the independent data-monitoring committee.
At this interim analysis, more patients in the surufatinib group than in the placebo group had partial responses (19% vs. 2%, respectively), objective responses (19% vs. 2%), tumor shrinkage (84% vs. 40%), and tumor shrinkage of more than 10% from baseline (68% vs. 15%).
Quality-of-life results did not differ between the groups, and overall survival data were not mature at the time of interim analysis.
Most patients in both groups had at least one treatment-emergent adverse event, but dose interruptions and dose reductions due to adverse events were more common with surufatinib (45% and 39%, respectively) than with placebo (24% and 5%).
"With the potent antitumor activity and differentiated safety profiles, surufatinib could be a treatment option in patients with advanced pancreatic NETs," Dr. Xu said. "Surufatinib might also have synergistic effects when combined with immunotherapy in advanced NETs or other solid tumors."
"Although this trial was done in an entirely Chinese patient population, the results appear to be generalizable to patients from North America and Europe," the authors say.
Hutchison MediPharma (Shanghai, China) funded the study and employed three of the authors of the report.
By Will Boggs MD
SOURCE: https://bit.ly/3iJiXnb Lancet Oncology, online September 20, 2020.
Posted on
site created by:
© 2024 Medicom Medical Publishers. All rights reserved. Terms and Conditions | Privacy Policy