Givastomig trial results presented on October 25, 2026, showed a 79% objective response rate among 29 evaluable patients receiving NovaBridge Biosciences’ selected dose alongside nivolumab and chemotherapy. The company said it has chosen the 8 mg/kg dose for further development and reached alignment with the US Food and Drug Administration on a Phase 3 study design.
Key Takeaways
- The ongoing Phase 1b analysis included 71 patients across two dose cohorts, with 29 evaluable for efficacy at the selected dose.
- NovaBridge reported no grade 4 or 5 treatment-related adverse events attributed to givastomig.
- The company plans an investor webcast on November 2 to discuss the data and its development strategy.
Givastomig trial results at the selected dose
NovaBridge presented the updated results at the European Society for Medical Oncology Congress in Madrid. The study is testing givastomig with nivolumab and chemotherapy as a first-line treatment for HER2-negative metastatic gastroesophageal adenocarcinoma.
The analysis, with data through August 6, 2026, included patients in 8 mg/kg and 12 mg/kg dose cohorts. At the selected 8 mg/kg dose, 23 of 29 efficacy-evaluable patients had an objective response, and 28 had disease control. Median follow-up was 17.8 months.
The company also reported objective response rates of 82% in patients whose tumors had CLDN18.2 expression of at least 75%, and 75% in those with expression between 1% and 74%. Results from the combination do not isolate the effect of givastomig.
| Item | Details |
|---|---|
| Objective response rate | 79% (23 of 29 efficacy-evaluable patients at 8 mg/kg) |
| Disease control rate | 97% (28 of 29 efficacy-evaluable patients at 8 mg/kg) |
| Median response duration | 15.2 months at 8 mg/kg |
| Median progression-free survival | 16.9 months at 8 mg/kg |
Safety and development plans
NovaBridge said immune-related adverse events were uncommon apart from gastritis, most cases of which were grade 2. It selected the 8 mg/kg dose based on the combined efficacy, safety and follow-up data.
The company said its discussions with the FDA informed the planned Phase 3 strategy, including the intended patient population, dose and primary endpoints. Givastomig has received orphan drug and fast track designations; those designations and agreement on a study design do not constitute approval.
Givastomig is also being evaluated in a global, randomized Phase 2 study, the company said.
Next milestone
NovaBridge will discuss the results and its registrational development strategy at an investor webcast on November 2, 2026, at 8:00 a.m. Eastern time.
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