CAMBRIDGE, Mass. & BEIJING– BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that the China National Medical Products Administration (NMPA) has approved BeiGene’s anti-PD-1 antibody tislelizumab as a second- or third-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). A supplemental biologics license application for tislelizumab in this indication was previously accepted for review by the China NMPA in March 2021.
“This latest approval for tislelizumab demonstrates BeiGene’s commitment to bringing innovative, impactful treatments to patients in need. With six approved indications in China, tislelizumab has the potential to reach and help the country’s large patient community, and our science-based commercial team of nearly 3,000 people in China is working to make it more broadly available to those who may benefit from this important immunotherapy,” commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene. “As our strategic oncology collaboration with Novartis deepens, we look forward to continued opportunities to expand access to tislelizumab globally and further explore its therapeutic potential.”
“As its third approved lung cancer indication in China, today’s approval represents an important milestone, with tislelizumab now available in both front-line and second- or third-line care of NSCLC. We hope, as demonstrated in the promising results from the global RATIONALE 303 trial, that tislelizumab will become an important treatment option for these patients in China,” commented Yong (Ben) Ben, M.D., Chief Medical Officer, Solid Tumors at BeiGene. “Tislelizumab’s broad global development program of 13 Phase 3 trials and four pivotal Phase 2 trials is providing a growing body of clinical evidence on its efficacy and safety and establishing its therapeutic impact across multiple cancer types.”
“In the global Phase 3 trial, tislelizumab demonstrated a significant improvement in overall survival and was well-tolerated in patients with previously treated NSCLC,” said Caicun Zhou, M.D., Ph.D., Director of the Department of Oncology at Shanghai Pulmonary Hospital, Director of Cancer Institute of Tongji University, and the principal investigator of the trial. “The NMPA’s approval of tislelizumab is welcoming news to the lung cancer community in China, and we hope this immunotherapy will help address the unmet needs in second- or third-line treatment of NSCLC.”
The approval of tislelizumab was supported by clinical results from a randomized, open-label, global Phase 3 trial RATIONALE 303 (NCT03358875) comparing tislelizumab to docetaxel in the second- or third-line setting in patients with locally advanced or metastatic NSCLC who have progressed on prior platinum-based chemotherapy. A total of 805 patients in 10 countries across Asia, Europe, the Americas, and Oceania were enrolled in the trial, randomized 2:1 to either the tislelizumab arm or the docetaxel arm.
As announced in November 2020, the trial met the primary endpoint of overall survival (OS) at the planned interim analysis, as recommended by the independent Data Monitoring Committee (IDMC). Tislelizumab was generally well-tolerated, consistent with known safety risks from previously reported results across different tumor types, with no new safety signals identified. The results of the interim analysis of the trial were presented at the American Association for Cancer Research (AACR) Annual Meeting and announced by BeiGene in April 2021.
