The P-III study (GEMSTONE-304) evaluating sugelimab (anti-PD-L1 IgG4 mAb) + CT (fluorouracil + cisplatin) vs PBO + CT in patients with unresectable LA, recurrent or metastatic ESCC
The trial met its 1EPs & showed an improvement in PFS & OS as assessed by BICR and the difference was statistically significant & clinically meaningful. The safety results were consistent with prior study results with no new safety signal while 2EPs incl. investigator-assessed PFS, BICR, ORR & DoR
The company intends to submit MAA of Zegema (sugelimab) in China in the near future & the results data will be highlighted at an international academic conference. In the P-Ib study, ORR (67.6%), and DCR (89.2%) & the response was sustainable
Ref: CStone | Image: CStone
Related News:- CStone Reports NMPA Acceptance of sNDA and Granted Priority Review for Sugemalimab to treat Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma
