Benzinga | Jan 14, 2021 05:55AM EST

Beigene Announced China National Medical Products Administration Approves Tislelizumab in Combination with Chemotherapy in First-Line Advanced Squamous Non-Small Cell Lung Cancer

BeiGene, Ltd. (NASDAQ:BGNE) announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) for use in combination with two chemotherapy regimens as a first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC). This is the third approval in China for tislelizumab, and its first in a lung cancer indication.

"This approval for tislelizumab is an important milestone for BeiGene, for tislelizumab, and for the patients and healthcare practitioners in China fighting advanced squamous NSCLC," commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. "This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients."

"With the recent announcement that the RATIONALE 303 trial met its primary endpoint of overall survival at its interim analysis, three Phase 3 trials of tislelizumab in NSCLC have achieved a positive outcome at interim analysis," commented Yong (Ben) Ben, M.D.,Chief Medical Officer, Immuno-Oncology at BeiGene. "Tislelizumab is being investigated in a broad clinical program, including five Phase 3 trials in lung cancer indications. We believe that it is an important immunotherapy and demonstrates our work at BeiGene to bring innovative, impactful, and quality treatments to patients in need."

"Lung cancer is the leading cause of cancer-related death in China, and with NSCLC comprising the most common form of the disease, there is significant patient need. We are grateful to have a new treatment available in the front-line setting for patients with advanced squamous non-small cell lung cancer," said Jie Wang, M.D., Ph.D., National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College. "In its Phase 3 trial in this indication, tislelizumab, combined with standard chemotherapy demonstrated a clinically meaningful benefit as assessed by progression-free survival and response rates."

"The approval of tislelizumab for patients with advanced squamous NSCLC was made possible by the courageous patients who participated in the trial, the dedicated clinicians who helped conduct the trial, and our hard-working team at BeiGene. We are humbled by the expeditious review of our supplemental new drug application and hope our broad development program for tislelizumab will continue its momentum and benefit additional patients," said Wendy Yan, Senior Vice President and Global Head of Regulatory Affairs at BeiGene.

The approval of tislelizumab for the treatment of patients with advanced squamous NSCLC was supported by clinical results from a Phase 3 trial of tislelizumab combined with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE®) and carboplatin compared to paclitaxel and carboplatin alone in patients with untreated stage IIIB or IV squamous NSCLC from mainland China (NCT03594747). A total of 360 patients were randomized 1:1:1 to receive tislelizumab in combination with either chemotherapy regimen or chemotherapy alone. As announced in January 2020, the trial met the primary endpoint of statistically significant improvement in progression-free survival (PFS), as assessed by independent review committee (IRC), in the pre-planned interim analysis. The safety profile of tislelizumab in both combinations was consistent with the known risks of each study treatment, and no new safety signals were identified. The results of the interim analysis of the trial were presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program.