I-Mab presented positive Phase 1b combination data for givastomig at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) in Barcelona. The data, from a study combining givastomig with nivolumab and mFOLFOX6, showed a confirmed objective response rate (ORR) of 71% across all doses (12/17 patients).
Crucially, at the 8 mg/kg and 12 mg/kg doses selected for the ongoing dose expansion study, givastomig demonstrated a confirmed ORR of 83% (10/12 patients). This high response rate was observed in tumors with low levels of PD-L1 and/or Claudin 18.2 expression, indicating broad applicability.
The combination therapy exhibited favorable overall tolerability, with no Grade 3 or greater events for nausea and vomiting, and only one Grade 3 treatment-related adverse event for increased liver enzymes. The median follow-up for the data was 9.0 months, with responses showing rapid onset and deepening over time.
ABL Bio, I-Mab's partner, highlighted that the 83% ORR observed with givastomig at selected doses compares favorably to the 40.3% ORR of zolbetuximab in combination with mFOLFOX6 chemotherapy in the SPOTLIGHT trial. This comparison underscores givastomig's potential competitive advantage as a first-line treatment for gastric cancers.
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