Shots:

• The sBLA is based on P-III RATIONALE 302 trial evaluating efficacy & safety of tislelizumab vs CT as a 2L treatment in 512 patients in a ratio (1:1) with locally advanced or metastatic ESCC across 11 countries
• The 1EPs of a trial is OS in ITT populations & 2EPs is OS in patients with high PD-L1 expression including PFS- ORR- DoR- & safety
• Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 mAb- designed to minimize binding to FcγR on macrophages. In Jan’21- BeiGene & Novartis have entered into a license agreement in which Novartis gets the rights to develop- manufacture & commercialize tislelizumab in North America- EU & Japan

  Ref: Businesswire | Image: Yicai Global