BeiGene’s tislelizumab receives China NMPA approval to treat patients with second-line ESCC

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BeiGene, Ltd. is a global, science-driven biotechnology firm dedicated to producing new and cost-effective medications to improve treatment outcomes and access for patients all over the world. The China National Medical Products Administration (NMPA) has approved BeiGene’s anti-PD-1 antibody, tislelizumab, as a treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression or are irradiated.

“As a second-line treatment for patients with ESCC, this differentiated checkpoint inhibitor demonstrated significant improvements in overall survival and was generally well-tolerated in our Phase 3 trial of tislelizumab. Tislelizumab regulatory submissions in this indication submitted by Novartis are under review by the U.S. FDA and the European Medicines Agency, highlighting our commitment to advancing its progress on behalf of the many patients around the world with ESCC and other forms of cancer,” 

commented Mark Lanasa, M.D., Ph.D., Senior Vice President, Chief Medical Officer, Solid Tumors, at BeiGene.

Clinical results from RATIONALE 302 (NCT03430843), a randomized, open-label, multi-center, global Phase 3 clinical trial evaluating the efficacy and safety of tislelizumab as a second-line treatment for patients with locally advanced or metastatic ESCC compared to chemotherapy, backed up the approval.

“With eight approved indications in China, our science-based commercial team of more than 3,100+ professionals is working to make tislelizumab more broadly available to those in China who may benefit from this important immunotherapy. Today’s approval is a great step for patients in China with ESCC,”

commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China, at BeiGene.

The trial’s primary endpoint is overall survival (OS) in the ITT population; a key secondary endpoint is OS in patients with high PD-L1 expression (defined as visually-estimated combined positive score [vCPS] 10%); and other secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), and safety. In the experiment, 512 patients were randomized 1:1 to either the tislelizumab or chemotherapy arm (investigator’s choice of paclitaxel, docetaxel, or irinotecan) in 11 countries and regions across Asia, Europe, and North America. The findings of this study were presented at the 2021 Annual Meeting of the American Society of Clinical Oncology (ASCO).

“The NMPA’s approval of tislelizumab is welcome news to patients with previously treated ESCC, for whom we are pleased to now be able to provide this new treatment option. The global Phase 3 clinical trial of tislelizumab demonstrated positive safety and efficacy outcomes as a second-line treatment for patients with ESCC, one of the most common malignant tumors in the digestive tract,”

said Lin Shen, Vice President of Clinical Oncology, Beijing Cancer Hospital, and the principal investigator of the trial. 

Tislelizumab is also undergoing regulatory evaluation in the United States and the European Union, as a second-line treatment for patients with locally progressed or metastatic ESCC, as filed by Novartis in their licensed areas.

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