Innovent and Eli Lilly Receive the NMPA’s Approval of Tyvyt (sintilimab) sNDA for EGFR-Mutated Non-Squamous NSCLC
- The NMPA has approved sNDA for Tyvyt in combination with bevacizumab & CT for EGFR-mutated non-sq. NSCLC who progressed after EGFR TKI therapy
- The approval was based on the P-III trial (ORIENT-31) evaluating Tyvyt with/out Byvasda & CT vs CT alone in 600 patients. As of the data cut-off date Mar 2022 in 2nd interim analysis, sustained PFS benefit was reported in the ITT population, m-PFS (7.2 vs 4.3mos.). In the 2EPs, improvement in ORR & DoR was seen
- As of the data cutoff date July 2022, OS benefit was seen, m-OS (21.1 vs 19.2mos.) while longer median time-to-deterioration of EORTC QLQ-C30 in the exploratory analyses of QoL & the safety profile was consistent with prior reported studies without new or unexpected safety signals. The results were published in the Lancet Respiratory Medicine
Ref: PRNewswire | Image: Innovent
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