BeiGene Reports NMPA’s Acceptance of sBLA for Tislelizumab to Treat Esophageal Squamous Cell Carcinoma in China

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

Click here to read full press release/ article | Ref: Businesswire | Image: Yicai Global