Beijing, China, Cambridge, Massachusetts, USA and Basel, Switzerland - January 2, 2024 - BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160; Shanghai Stock Exchange: 688235) is a global Biotechnology company. The company announced today that its new indication of PD-1 inhibitor TEVIMBRA®® (tislelizumab) has been approved by the China National Medical Products Administration (NMPA) as a single agent for the treatment of unresectable or metastatic hepatocellular carcinoma ( first-line treatment for patients with HCC).

Liver cancer is a common malignant tumor with high incidence in China. In 2020, there were about 410,000 new cases of liver cancer in China, accounting for about half of the global number; there were about 391,000 deaths, making it the second largest cause of cancer death in China1. 70%-80% of liver cancer patients are already in the intermediate and advanced stages when diagnosed, the opportunity for surgery or other local treatments is lost, and the clinical prognosis is poor. The 5-year survival rate is only 12.1%. More treatments are urgently needed to improve patient survival.

Dr. Wang Lai, senior vice president and global head of R&D at BeiGene, said: "The incidence of HCC in China has continued to increase in recent years, and there is a large unmet clinical need. This approval is the first step in the development of tislelizumab in China. Another breakthrough in the field of liver cancer has enriched the first-line treatment options for patients with advanced HCC. We hope that this new treatment option can benefit more liver cancer patients and further improve the survival benefits of liver cancer patients."

This approval is based on clinical trial data from RATIONALE 301 (NCT03412773). The trial is a randomized, open-label, global phase III clinical study that enrolled 674 patients from various research centers in Asia, Europe and the United States. It is designed to evaluate the efficacy of tislelizumab as the first-line treatment in adult patients with HCC compared with sorafenib in unresectable patients.

Previously, the results of the RATIONALE 301 trial were announced in the form of an oral report on the latest breakthrough at the 2022 European Society for Medical Oncology (ESMO) Congress in Paris, France, and were published in the famous journal "Journal of the American Medical Association-Oncology" in the field of oncology this year. (JAMA Oncology). The results of the study showed that compared with sorafenib, tislelizumab demonstrated non-inferior results in overall survival (OS). The median OS of tislelizumab was 15.9 months, while the OS of sorafenib was 14.1 months; tislelizumab had a higher objective response rate (ORR) (14.3% vs 5.4%) and more durable response (median duration of response (DoR) was 36.1 months and 11.0 months, respectively); the safety profiles of tislelizumab and sorafenib treatment were consistent with previous studies.

Professor Qin Shukui, chief expert on digestive system tumors at Nanjing Tianyinshan Hospital affiliated to China Pharmaceutical University and global leading PI of the RATIONALE 301 trial, said: "RATIONALE 301 is a prospective, randomized global multi-center phase III clinical trial led by Chinese experts. In the design and optimization phase of plan, the highly heterogeneous nature of liver cancer in the East and West was taken into account, while fully integrating China's national conditions, patient characteristics and practical experience; the trial process was scientifically implemented and strictly Quality control and detailed data have achieved the expected results, providing new options and reliable basis for first-line immunotherapy for patients with advanced hepatocellular carcinoma."

Professor Qin further said, “In this study, tislelizumab demonstrated excellent efficacy, safety and tolerability as a single-agent first-line treatment of liver cancer, and brought significant survival benefits, which is of great clinical significance. It is believed that after tislelizumab is approved for first-line treatment of advanced hepatocellular carcinoma, in addition to being used as a single agent, it will also promote the clinical application and research progress of combination regimens containing tislelizumab. It brings hope of life to many liver cancer patients."

So far, tislelizumab has been approved by the NMPA for 12 indications, making it the PD-1 inhibitor with the largest number of approved indications in China. 11 of these indications have all been included in the National Medical Insurance Drug List. It is also the PD-1 inhibitor with the largest number of approved indications in the National Medical Insurance Drug List.

https://www.beigene.com.cn/pressreleases/%e7%99%be%e6%b5%8e%e7%a5%9e%e5%b7%9epd-1%e6%8a%91%e5%88%b6%e5%89%82%e7%99%be%e6%b3%bd%e5%ae%89%ef%bc%88%e6%9b%bf%e9%9b%b7%e5%88%a9%e7%8f%a0%e5%8d%95%e6%8a%97%ef%bc%89%e5%9c%a8%e4%b8%ad%e5%9b%bd/

责编: editor