Updated Safety and Efficacy Analysis of Givastomig in Advanced Gastroesophageal Carcinoma

I-MAB has submitted a Form 6-K report detailing the updated safety, efficacy, and biomarker analysis from the Phase I monotherapy study of Givastomig, a novel Claudin 18.2/4-1BB bispecific antibody, in patients with Claudin 18.2 positive advanced gastroesophageal carcinoma (GEC). The study, which included 45 patients, showed that Givastomig was well tolerated up to 15 mg/kg Q2W and 18 mg/kg Q3W, with no dose-limiting toxicities observed. The confirmed overall response rate (ORR) was 18%, and the disease control rate (DCR) was 48.9%. The median progression-free survival (PFS) was 3.0 months, and the median overall survival (OS) was 7.5 months. The study found no statistically significant differences in ORR, DCR, PFS, or OS between CLDN18.2-high and CLDN18.2-low groups. The sustained tolerability and efficacy support the development of Givastomig as an add-on to first-line therapy in combination with nivolumab and mFOLFOX6 in advanced or metastatic gastric, gastroesophageal, and esophageal adenocarcinomas.