The first case of phase III study of global large-scale liver cancer of Baishi Shenzhou PD-1 monoclonal antibody tislilizumab

Source: the first global phase III clinical trial of PD-1 antibody tislilizumab in the treatment of advanced liver cancer (HCC) was announced on January 2, 2018 by medical magic formula in Baiji, Shenzhou, and was enrolled in December 2017 In addition to the two critical phase II clinical trials for recurrent / refractory classic Hodgkin's lymphoma and urothelial cancer in China and the global phase III clinical trials for non-small cell lung cancer patients, tislilizumab is currently undergoing critical trial evaluation in four different indications This phase III, open label, multicenter randomized trial was designed to compare the efficacy and safety of tislilizumab and sorafenib in the first-line treatment of patients with unresectable HCC It is planned to recruit about 640 patients from about 110 cancer centers in China, the United States, Japan, the United Kingdom, Germany, Spain, the Czech Republic, France and Italy Patients will be randomly treated with tislilizumab 200 mg per 3 weeks or sorafenib 400 mg twice a day The primary end point of the trial was overall survival, and the secondary end points included overall remission rate, progression free survival period, duration of remission, progression time, health-related quality of life, disease control rate, clinical benefit rate and safety "We are very pleased to announce this global phase 3 trial of tislilizumab, which has been officially launched as part of our cooperation plan with the new base company," said Ou Lei Qiang, founder, CEO and chairman of Baiji Shenzhou We are looking forward to making full use of our strong ties in Asia and our global clinical development organization to comprehensively promote the clinical development of tislilizumab " Amy Peterson, M.D., chief medical officer of tumor immunology of Baiji Shenzhou, said: "advanced liver cancer is a serious and high incidence cancer, and the treatment options are very limited We hope that this phase III clinical trial can establish the safety and effectiveness of tislilizumab through head-to-head comparison with solafeni, the current global standard treatment scheme for advanced liver cancer "The median survival time of patients with advanced liver cancer is usually less than one year, and some patients may be intolerable to sorafenib," said Qin Shukui, MD, deputy director of the eighth hospital of the Chinese people's Liberation Army and director of the cancer center of the whole army "Professor Qin is also one of the co lead researchers of this clinical trial He said:" I am looking forward to the clinical trial of tislilizumab, and hope that It can further promote the treatment options of patients with advanced liver cancer " "I am very pleased to have the opportunity to participate in the assessment of the safety and efficacy of tislilizumab, which has been administered to more than 850 patients as a single or combined drug," said Andrew Zhu, MD, director of the cancer research center at Massachusetts General Hospital, Professor of medicine at Harvard Medical School and co lead researcher of this clinical trial Based on the preliminary data of some HCC patients in the phase I clinical trial, we expect tislilizumab to show good tolerance and excellent antitumor activity in the phase III clinical trial "