I-Mab’s givastomig shows positive response rate in gastric cancer trial

I-Mab (IMAB) announced publication of an abstract related to positive data from a Phase 1b study evaluating givastomig in combination with nivolumab and mFOLFOX6 chemotherapy for metastatic gastric cancers. An objective response rate of 71% – 12/17 – was observed across all dose levels with an ORR of 83% observed at dose levels selected for the ongoing dose expansion study. Responses were rapid and deepened over time. There was a favorable safety profile, with low incidence of GI and liver toxicities. The CLDN-Low response rate increased to 100% of patients (3/3) in the doses selected for expansion. The disease control rate was 100% across the three dose levels. Patients also experienced a dose dependent induction of soluble 4-1BB, a positive indicator of T cell activation and engagement. No dose limiting toxicities were observed and a maximum tolerated dose was not reached. Grade 3 TRAEs attributed to givastomig were rare, with single cases of abdominal pain, ALT/AST increases, gastritis, and infusion related reaction. No Grade 4 or Grade 5 TRAEs were reported.