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“We are pleased to announce the initiation of this global Phase 3 trial of tislelizumab as part of our collaboration with our partner
“Advanced liver cancer is a serious and prevalent disease, with few treatment options. We are hopeful that this Phase 3 trial will establish safety and efficacy of tislelizumab in a head-to-head comparison to sorafenib, the current global standard of care for advanced liver cancer,” commented
The Phase 3, open-label, multi-center, randomized trial is designed to compare the efficacy and safety of tislelizumab versus sorafenib as a potential first-line treatment in patients with unresectable HCC. Approximately 640 patients will be enrolled at approximately 110 cancer centers in
The trial’s primary endpoint is overall survival, and secondary endpoints include overall response rate, progression free survival, duration of response, time to progression, health-related quality of life, disease control rate, clinical benefit rate, and safety profile.
“The expected median survival in patients with advanced liver cancer is typically less than one year, and patients can face difficulties tolerating sorafenib,” said Qin Shukui, M.D., Hospital Deputy Director and Director of the Cancer Center at the People’s Liberation Army 81 Hospital,
“I am excited for the opportunity to evaluate the safety and efficacy of tislelizumab, which has been dosed in more than 850 patients in either monotherapy or combination clinical trials. Based on preliminary data from a dose expansion cohort of HCC patients in a Phase 1 trial, we are hopeful that tislelizumab will be well-tolerated and exhibit meaningful anti-tumor activity in this Phase 3 trial,” said Andrew Zhu, M.D., Ph.D., Director of
For more information about the trial, patients and physicians should email
About Hepatocellular Carcinoma
HCC is a major global health problem, accounting for 85-90 percent of all reported cases of liver cancer.i Liver cancer is the sixth most common type of cancer, with an estimated 782,000 new cases per year worldwide; it was also the second most common cause of cancer-related mortality, responsible for an estimated 746,000 deaths.ii
About Tislelizumab (BGB-A317)
Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene’s advancement of, and anticipated clinical development and regulatory milestones and plans related to tislelizumab. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including
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i Nordenstedt H, White DL, El-Serag HB. The changing pattern of epidemiology in hepatocellular carcinoma. Digestive and Liver Disease. 2010;42(Suppl 3):S206-S214. doi:10.1016/S1590-8658(10)60507-5.
ii GLOBOCAN 2012: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Accessed
iii ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks of