Innovent and Lilly’s Tyvyt (sintilimab injection) + Gemcitabine and Platinum CT Receive NMPA’s Approval as 1L Therapy for Squamous Non-Small Cell Lung Cancer

June 4, 2021 Auto Bot approval, Innovent, Lilly, NMPA, regulatory, Tyvyt 0

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

Click here to­ read full press release/ article | Ref: PR Newswire | Image: Lixoft

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