BeiGene Reports NMPA’s Acceptance of sBLA for Tislelizumab to Treat MSI-H or dMMR Solid Tumors

Shots:

• The sBLA submission is based on results from a P-II study evaluating the efficacy & safety of tislelizumab (200 mg, IV, q3w) as monothx in 80 patients with previously treated LA, unresectable or metastatic MSI-H or dMMR solid tumors
• The results demonstrated that the therapy treatment was consistent & durable across tumor types and EPs while 1EPs of the trial is ORR and 2EPS include time to response, DoR, DCR, and PFS as assessed by investigator & IRC, OS & evaluates the safety and tolerability
• Tislelizumab is a humanized IgG4 anti-PD-1 mAb specifically designed to minimize binding to FcγR on macrophages. The BLA marks 7th indication for tislelizumab

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