BeiGene drug approved for lung cancer use in China

Biotech company BeiGene Ltd announced Thursday its anti-PD-1 antibody tislelizumab has received approval from the country's National Medical Products Administration for use in combination with two chemotherapy regimens as a first-line treatment for patients with advanced squamous non-small cell lung cancer.

That marked 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 patients and healthcare practitioners in China fighting advanced squamous non-small cell lung cancer," said Wu Xiaobin, president of the company and general manager of its China arm.

"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."

"Lung cancer is the leading cause of cancer-related death in China, and with non-small cell lung cancer comprising the most common form of the disease, there is significant patient need," said Wang Jie, an oncologist with the National Cancer Center/Cancer Hospital under the Chinese Academy of Medical Sciences & Peking Union Medical College.

In 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, Wang said

A total of 360 patients were randomized 1:1:1 to receive tislelizumab in combination with either chemotherapy regimen or chemotherapy alone during the trial. As announced in January 2020, the trial met the primary endpoint of statistically significant improvement in progression-free survival, as assessed by the independent review committee, 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 Virtual Scientific Program.