Chi-Med Initiates a Phase II Trial of Surufatinib in Combination with Tuoyi in Patients with Advanced Solid Tumors

LONDON, Jan. 13, 2020 (GLOBE NEWSWIRE) — Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated a Phase II study in China of surufatinib in combination with Tuoyi (toripalimab) in patients with advanced solid tumors. This follows the recent completion of the Phase I dose finding study and successful establishment of the Phase II combination dosing regimen for surufatinib and Tuoyi.

This China Phase II clinical study is part of a global collaboration with Shanghai Junshi Biosciences Co. Ltd. (“Junshi”), to evaluate surufatinib, Chi-Med’s oral angio-immuno kinase inhibitor, in combination with Tuoyi, Junshi’s anti-programmed cell death protein 1 (“PD-1”) monoclonal antibody which was approved by China’s National Medical Products Administration (“NMPA”) in December 2018. The study is designed to test the potential synergistic anti-tumor effects of the combination’s ability to simultaneously target multiple cell types and signaling pathways in the tumor microenvironment.

The Phase II study plans to explore multiple solid tumor patient populations. The primary outcome measures are objective response rate (ORR) and safety. The secondary outcomes include duration of response (DoR), progression-free survival (“PFS”), disease control rate (DCR) and overall survival (“OS”). The lead principal investigator of the study is Professor Lin Shen, Vice President of Peking University Hospital and Cancer Institute. Additional details may be found at clinicaltrials.gov, using identifier NCT04169672.

Christian Hogg, Chief Executive Officer of Chi-Med, said, “We are excited to move into Phase II development on the surufatinib toripalimab combination and look forward to identifying patient groups that could benefit from this innovative treatment regimen.”

In December 2019, surufatinib was granted Priority Review status by the Center for Drug Evaluation (CDE) of China’s NMPA for its New Drug Application (“NDA”) for the treatment of patients with advanced non-pancreatic neuroendocrine tumors (“NET”).

In November 2019, the NDA for surufatinib for the treatment of non-pancreatic NET was accepted for review by the NMPA, and the U.S. Food and Drug Administration granted Orphan Drug designation to surufatinib for the treatment of pancreatic NET.

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