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

  | Ref: Businesswire | Image: Forbes