I-Mab Announces Publication of Givastomig Monotherapy Data in Clinical Cancer Research

Core Insights - I-Mab announced the publication of first-in-human monotherapy data for givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, showing an objective response rate (ORR) of 16% in heavily pretreated Claudin 18.2-positive gastric cancer patients [1][2][4] Summary of Monotherapy Results - The Phase 1 monotherapy study evaluated 75 patients, with 43 being efficacy-evaluable for advanced or metastatic gastroesophageal carcinoma (GEC) [2][5] - The ORR increased to 18% after the enrollment of two additional patients, resulting in 8 out of 45 patients achieving a confirmed partial response (PR) [2][6] - The study demonstrated a disease control rate (DCR) of 49% among the efficacy-evaluable patients [7] Safety and Tolerability - Givastomig was well tolerated, with no dose-limiting toxicity reported up to 15 mg/kg dosed every two weeks and 18 mg/kg dosed every three weeks [15] - The most common treatment-related adverse events were mainly Grade 1 or 2 [15] Development Strategy - The findings support the development of givastomig in combination with standard immunochemotherapy (nivolumab plus mFOLFOX6) as a first-line treatment for gastric cancers [3][4] - An ongoing Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy, with enrollment progressing ahead of schedule [10] Unique Mechanism - Givastomig's bispecific design allows for high binding affinity to Claudin 18.2-positive cancer cells, enabling localized T cell stimulation while minimizing gastrointestinal toxicity [4][9]