- Givastomig achieved an 18% objective response rate (ORR) in heavily pretreated gastric cancer patients.
- Demonstrated activity across a wide range of Claudin 18.2 expression levels (11% to 100%).
- No dose-limiting toxicity reported up to 18 mg/kg, with a median response duration of 9.4 months.
I-Mab (IMAB, Financial), a U.S.-based biotech company, has published promising results for its bispecific antibody, givastomig, in the journal Clinical Cancer Research. The Phase 1 study explored the efficacy of givastomig monotherapy in patients with Claudin 18.2-positive gastric cancer who had undergone extensive prior treatments.
The study evaluated 75 patients, including 43 who were eligible for efficacy analysis. Givastomig achieved a notable objective response rate (ORR) of 18%. Patient responses were confirmed across various levels of Claudin 18.2 expression, from 11% to 100%, highlighting the drug's potential wide applicability.
The disease control rate (DCR) was reported at 49%, with a significant median duration of response of 9.4 months. Importantly, there were no dose-limiting toxicities observed up to the highest doses tested (15 mg/kg every two weeks and 18 mg/kg every three weeks), indicating a favorable safety profile.
Building on these monotherapy results, I-Mab is advancing towards combining givastomig with nivolumab and mFOLFOX6 chemotherapy as a first-line treatment for gastric cancers. Preliminary data from this combination treatment will be shared at the upcoming ESMO GI Cancers Congress in 2025 in Barcelona, potentially reinforcing givastomig's role as a best-in-class treatment option.
