Shots:

• The approval is based on P-III ORIENT-12 trial evaluating Tyvyt (sintilimab injection) or PBO + Gemzar (gemcitabine) & platinum CT in 357 patients in a ratio (1:1) as 1L therapy for advanced or metastatic sqNSCLC
• Results: Improvement in PFS & OS- m-PFS (5.5 vs 4.9 mos.) as assessed by IRRC & (6.7 vs 4.9 mos.) as assessed by study's investigators- m-OS was not mature- safety is consistent with previous studies & no new safety signals were identified
• Sintilimab is an innovative PD-1 inhibitor & approval marks the 3rd indication for therapy. The company is currently conducting 20+ clinical studies of sintilimab for different types of cancer- includes 10+ registrational or clinical trials

  Ref: PR Newswire | Image:Innovent