I-Mab Showcases Encouraging Givastomig Phase 1b Data
Recent data shows an objective response rate (ORR) of 83% in patients at targeted doses.
Follow-up indicates promising durability in treatment responses.
ROCKVILLE, Md. — I-Mab (NASDAQ: IMAB), a U.S.-based biotech company specializing in innovative cancer treatments, recently unveiled positive results from its Phase 1b clinical study for givastomig. This data was presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 (ESMO GI 2025). Givastomig is a bispecific antibody that effectively targets Claudin 18.2 and 4-1BB proteins.
The data reveals a solid confirmed ORR of 71% across all treated patients, improving to 83% at specific doses chosen for further study. Notably, adequate responses were identified in patients exhibiting low PD-L1 and/or Claudin 18.2 expressions. Side effects were minimal, with no significant adverse events recorded among patients.
Clinical Study Overview
The Phase 1b trial (NCT04900818) involved 17 advanced metastatic gastric cancer patients who were previously untreated and had measurable disease defined by strict criteria. Patients exhibited Claudin 18.2 positivity, regardless of PD-L1 expression. Importantly, the study primarily targeted first-line treatment scenarios.
The main endpoints of this study focused on safety and response rates. Results showed that the doses of 8mg/kg and 12mg/kg were particularly effective, where 83% of patients achieved a partial response.
Key Efficacy Results
As analyzed, 71% of patients responded positively across all cohorts. Significant findings include:
- At doses designated for expansion, an impressive 83% achieved partial responses.
- A complete disease control rate of 100% was noted.
- Low levels of gastrointestinal side effects were observed, crucial for this patient demographic.
“These findings reinforce our belief that givastomig may lead the way as a premier therapy for Claudin 18.2 positive cancers,” stated Dr. Phillip Dennis, I-Mab's Chief Medical Officer. “The trial highlights exceptional response rates and manageable safety, which are critical in optimizing treatment for gastric cancer patients.”
Safety Profile and Tolerability
The safety aspects examined in the study affirmed the combination's acceptability, emphasizing that:
- The treatment-related adverse events (TRAEs) were predominantly grade 1 or 2.
- Only a small portion underwent treatment discontinuation due to adverse effects.
- No dose-limiting toxicities emerged, allowing for an expansive treatment window.
Broader Implications for Gastric Cancer Treatment
Givastomig is poised to significantly impact the treatment landscape for gastric cancers, which currently lack efficient targeted therapies. Clinical trials are advancing swiftly, with hopes of expanding options for eligible patients and continuing enrolment in various cohorts.
As sophistication in cancer therapy builds, I-Mab strives to solidify its place as a frontrunner in oncological innovation with the promising results from this study leading the way.
Frequently Asked Questions
What is givastomig?
Givastomig is a bispecific antibody that targets Claudin 18.2 and 4-1BB, designed to enhance T-cell activation and activity against tumors.
What were the main findings of the Phase 1b study?
The study reported a confirmed objective response rate of 71% overall, improving to 83% for specific doses with favorable safety outcomes.
How many patients were involved in this study?
A total of 17 patients with advanced metastatic gastric cancer participated in the trial.
What is the significance of Claudin 18.2 in this research?
Claudin 18.2 positivity is crucial as it helps identify suitable candidates for givastomig treatment, leveraging the antibody's targeted effects.
What are the next steps for I-Mab regarding givastomig?
I-Mab plans to continue clinical studies, particularly focusing on expanding treatment cohorts and gathering further data on givastomig’s efficacy.
