BeiGene Reports NMPA’s Acceptance of sBLA for Tislelizumab (BGB-A317) to Treat Nasopharyngeal Cancer in China

Shots:

• The sBLA is based on P-III RATIONALE 309 trial evaluating the efficacy & safety of tislelizumab + CT vs PBO + CT in a ratio (1:1) in 263 Asian patients with recurrent or metastatic NPC
• The 1EPs of a trial is PFS as assessed by IRC in ITT population & 2EPs includes OS, ORR, DoR, investigator-assessed PFS, the safety profile was consistent with its known risks with no new safety signals observed with an addition of CT
• Tislelizumab is a humanized IgG4 anti-PD-1 mAb, designed to minimize binding to FcγR on macrophages. In Jan’21, BeiGene & Novartis entered into a license agreement in which Novartis got rights to develop, manufacture & commercialize the therapy in North America, EU & Japan

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