Innovent’s Tyvyt (sintilimab) + Pemetrexed and Platinum CT Receives NMPA’s Approval as 1L Therapy with Non-squamous Non-Small Cell Lung Cancer

February 3, 2021 Auto Bot 1L, approval, combination, CT, Innovent, NMPA, receives, regulatory, therapy 0

Shots:

  • The approval follows P-III ORIENT-11 study assessing Tyvyt (sintilimab) vs PBO + Almita (pemetrexed) and platinum CT in 397 participants in a ratio (2:1) as 1L therapy for advanced or recurrent nsqNSCLC
  • Results: Improvement in PFS, as assessed by IRC; mPFS (8.9 vs 5.0mos.); safety profile is consistent with previously reported studies with no new safety signals. At updated analysis after extended follow up, mOS (not reached vs 16.0 mos.)
  • Sintilimab is an innovative PD-1 inhibitor, jointly developed by Eli Lilly and Innovent. The approval marks the second indication for sintilimab in China, following the first approved indication r/r classical Hodgkin’s lymphoma after at least 2L of systemic CT

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PRNewswire

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