Shots:

• The approval is based on Tislelizumab + CT regimen vs CT as monothx. in 360 patients with a ratio (1:1:1) as a 1L for patients with advanced squamous NSCLC
• The trial met the 1EP- i.e. improvement in PFS- as assessed by 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
• Tislelizumab is a humanized IgG4 anti-PD-1 mAb specifically designed to minimize binding to FcγR on macrophages. The approval marks the third approval for tislelizumab in China and its first in a lung cancer indication

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