BeiGene’s tislelizumab gets China approval for non-small cell lung cancer
pharmafile | January 14, 2021 | News story | | BeiGene, Cancer, tislelizumab
BeiGene Ltd has 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).
The approval is tislelizumab’s third approval in China, and its first in a lung cancer indication.
Authorisation of BeiGene’s drug for use in patients with advanced squamous NSCLC was supported by clinical results from a Phase III trial of tislelizumab combined with either paclitaxel and carboplatin or nab-paclitaxel and carboplatin, compared with paclitaxel and carboplatin alone in Chinese patients with untreated stage IIIB or IV squamous NSCLC.
In the randomised trial, a total of 360 patients received tislelizumab in combination with either chemotherapy regimen or chemotherapy alone. According to results published in January last year, the trial met the primary endpoint of statistically significant improvement in progression-free survival, as assessed by independent review committee, in the pre-planned interim analysis. The safety profile of the drug in both combinations was consistent with the known risks of each study treatment, and no new safety signals were identified.
Dr Jie Wang, of the National Cancer Center at the Chinese Academy of Medical Sciences & Peking Union Medical College, said: “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.
“In its Phase III trial in this indication, tislelizumab, combined with standard chemotherapy demonstrated a clinically meaningful benefit as assessed by progression-free survival and response rates.”
Darcy Jimenez
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