The NMPA has approved sNDA for Tyvyt in combination with cisplatin + paclitaxel or cisplatin + 5-fluorouracil CT for unresectable, LA, recurrent or m-ESCC regardless of PD-L1 expression status
The approval was based on the interim analysis of the P-III (ORIENT-15) trial evaluating sintilimab + CT vs PBO + CT in a ratio (1:1) in 659 patients which showed an improvement in OS & PFS with m-OS (16.7mos. vs 12.5mos.) & m-PFS (7.2mos. vs 5.7mos.) thus meeting the pre-defined efficacy criteria. The safety profile was consistent with prior reported studies of sintilimab without new or unexpected safety signals
The therapy was approved in China for r/r CHL & other indications. Lilly will provide high-quality, affordable drugs & effective treatment options to Chinese patients
Ref: PRNewswire | Image: Innovent
