I-Mab To Present Positive Updated Givastomig Monotherapy Data at 2025 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference on October 23, 2025

Core Insights - I-Mab announced updated data from the Phase 1 study of givastomig, a bispecific antibody targeting CLDN18.2 and 4-1BB, showing an 18% objective response rate (ORR) in heavily pre-treated gastroesophageal carcinoma patients [1][2][7] Study Data Summary - The Phase 1 study involved 45 patients with a median of 3 prior therapies, demonstrating an ORR of 18% with responses across a dose range from 5 mg/kg Q2W to 18 mg/kg Q3W [2][7][13] - No differences in efficacy were observed across varying levels of CLDN18.2 expression, with a disease control rate (DCR) of 49% [7][13] - The median progression-free survival (mPFS) was 2.96 months and median overall survival (mOS) was 7.49 months [13] Safety Profile - Givastomig was well tolerated, with no dose-limiting toxicities reported, and common treatment-related adverse events (TRAEs) included anemia (27%), white blood cell count decrease (22%), and nausea (20%) [10][13] Future Plans - I-Mab plans to report topline results from the Phase 1b dose expansion study and initiate a global randomized Phase 2 study in Q1 2026 [2][7] - The upcoming presentation at the Triple Meeting on October 23, 2025, will provide further insights into the safety and efficacy of givastomig [4][5] Market Potential - The treatment strategy for givastomig is anchored in the first-line gastric cancer market, which is estimated to be a $2 billion potential market [7]