CStone Reports P-III Study (GEMSTONE-304) Results of Sugelimab as 1L Treatment of Esophageal Squamous Cell Carcinoma
Shots:
- 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
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