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LSK BioPharma and Jiangsu Hengrui Medicine announce enrollment of the first patient in a phase 3 clinical study
LSK BioPharma (or “LSKB”), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or “Hengrui”), one of the largest and most innovative fully-integrated biopharmaceutical companies based in China, today announced the first patient has been enrolled in a pivotal global phase 3 clinical study of PD-1 antibody camrelizumab (SHR-1210) plus rivoceranib (commonly known as apatinib) versus sorafenib as a first-line therapy in subjects with advanced hepatocellular carcinoma (HCC). Rivoceranib, a selective VEGFR-2 inhibitor commonly known as apatinib, was approved in 3rd line gastric cancer in China in December 2014. Camrelizumab is a humanized anti-PD-1 monoclonal antibody which recently received the approval in China for classic Hodgkin’s Lymphoma (cHL).
“We are excited to study the potential synergies of rivoceranib with immunotherapy and demonstrate the benefits to HCC patients in a first line setting,” said Dr. Steve Norton, Vice President of Drug Development at LSKB.
Hengrui has been conducting an open-label, single arm multicenter phase 2 study (NCT03463876) to evaluate the efficacy and safety of the combination of camrelizumab and apatinib in patients with advanced HCC in China, where Hengrui has received approval of apatinib monotherapy for advanced gastric cancer. At ASCO 2018, it was reported that the objective response rate (ORR) and disease control rate (DCR) were 50.0% and 85.7%, respectively, among 14 evaluated advanced HCC patients treated by camrelizumab in combination with apatinib in an open-label, phase 1 study in China (Xu et al., NCT02942329). In addition, camrelizumab and apatinib combination therapy is also being evaluated by Hengrui for multiple indications including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and gastric cancer (GC) in China.
Based upon earlier studies, it is hypothesized that the combination of rivoceranib and camrelizumab may enhance the immune system, aiding the fight against cancer. In addition to the known anti-angiogenic effects of rivoceranib, it may also enhance camrelizumab’s anti-tumor activity by normalizing tumor vasculature and reversing the tumor suppressive immune microenvironment.