On March 29, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it has initiated a registration-enabling Phase IIb/III study comparing surufatinib (HMPL-012 or sulfatinib) with capecitabine in patients with advanced biliary tract cancer ("BTC") whose disease progressed on first-line chemotherapy (Press release, Hutchison China MediTech, MAR 29, 2019, http://www.chi-med.com/initiates-phase-iib-iii-suru-btc-china/ [SID1234534752]). This major unmet medical need is a heterogeneous group of rare malignancies arising from the biliary tract epithelia and the gallbladder. The first patient was dosed on March 22, 2019 in China.
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The study is a randomized, open-label, active-control, multi-center, study investigating the effects of surufatinib, an oral small molecule angio-immuno kinase inhibitor that can simultaneously block tumor angiogenesis and immune evasion, versus the chemotherapy agent capecitabine, as a second-line therapy in patients with unresectable or metastatic BTC. The primary endpoint is overall survival (OS). Secondary outcomes include measures of tumor control such as progression free survival ("PFS"), objective response rate (ORR), disease control rate (DCR), and duration of response (DOR), quality of life, tumor biomarkers, and safety. The lead investigator of the study is Professor Jianming Xu of the Department of Gastrointestinal Oncology, the Fifth Medical Center, General Hospital of the People’s Liberation Army. Additional details may be found at clinicaltrials.gov, using identifier NCT03873532.
This study complements a Phase Ib/II proof-of-concept study of surufatinib in China (clinicaltrials.gov identifier: NCT02966821) in BTC as well as a Phase Ib study in the US enrolling patients with BTC and pancreatic neuroendocrine tumors ("NET") (clinicaltrials.gov identifier: NCT02549937). Results of the Phase Ib/II proof-of-concept BTC study is expected to be submitted for publication in 2019.
About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies. In addition to the BTC studies, surufatinib is in proof-of-concept clinical trials in the U.S. and several proof-of-concept and late-stage clinical trials in China.
Pancreatic NET in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pancreatic NET in China. The primary endpoint is PFS. We expect to deliver an interim analysis in late 2019 and complete enrollment in 2020 (clinicaltrials.gov identifier: NCT02589821).
Non-pancreatic NET in China: In December 2015, we initiated the SANET-ep study, which is a pivotal Phase III study in patients with low or intermediate grade advanced non-pancreatic NET in China. The primary endpoint is PFS. We expect to deliver an interim analysis in mid-2019 and complete enrollment in 2020. (clinicaltrials.gov identifier: NCT02588170).
Pancreatic NET in the U.S. and Europe: The encouraging data from the Phase II study of surufatinib in pancreatic NET in China (clinicaltrials.gov identifier: NCT02267967), and the ongoing Phase Ib study in the U.S., have led us to decide to proceed with planning a registration study in pancreatic NET patients.
Immunotherapy combinations: In November 2018, we entered into two collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with checkpoint inhibitors. These include a global collaboration to evaluate the combination of surufatinib with Tuoyi (toripalimab, JS001), a PD-1 monoclonal antibody approved in China in late 2018 by Shanghai Junshi Biosciences Co. Ltd. and a collaboration in China to evaluate the combination of surufatinib with HX008, a PD-1 monoclonal antibody being developed by Taizhou Hanzhong Pharmaceuticals, Inc.. Safety run-in studies are currently being planned/underway to establish the safe and effective dose regimens for the surufatinib combinations with both Tuoyi and HX008.