Hutchison China MediTech has stopped a phase 3 trial of surufatinib in pancreatic neuroendocrine tumors early for positive efficacy. An independent data monitoring committee found the trial had hit its primary endpoint by the time of an interim analysis, enabling Chi-Med to stop the study and start work on a filing for approval.
Surufatinib is an oral angio-immuno kinase inhibitor designed to both inhibit the formation of new blood vessels and promote antitumor immune responses, giving it a dual mechanism of action that Chi-Med thinks will make it suitable for use in immunotherapy combinations.
For now though, the focus is on the use of surufatinib as a monotherapy. Surufatinib has cleared the monotherapy tests put in front of it to date, first coming through a phase 3 trial in advanced extrapancreatic neuroendocrine tumors and now showing efficacy in pancreatic neuroendocrine tumors.
The latest trial to read out enrolled close to 200 patients with advanced pancreatic neuroendocrine tumors in China and randomized them to receive surufatinib or placebo once a day for a month. Chi-Med is yet to share data from the trial, but the progression-free survival results were strong enough for the data committee to recommend stopping the study at a pre-planned interim analysis.
Equipped with the phase 3 data, Chi-Med plans to meet with Chinese regulators to discuss filing for approval of surufatinib in patients with pancreatic neuroendocrine tumors. A filing for approval of the drug in non-pancreatic neuroendocrine tumors is already being assessed by China’s National Medical Products Administration, which put it on its priority review pathway late last year.
Chi-Med CEO Christian Hogg thinks the back-to-back clinical successes position surufatinib to carve out a niche in the treatment of 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,” Hogg said.
Chi-Med is now building up a sales and marketing team in China ahead of trying to turn surufatinib into a significant commercial product. Plans are less advanced in the U.S., where Chi-Med is testing the drug in proof-of-concept trials.