NovaBridge Presents Positive Givastomig Dose Expansion Data from the Phase 1b Combination Study in Patients with 1L Metastatic Gastric Cancer

Core Insights - NovaBridge Biosciences announced positive results from the Phase 1b study of givastomig, a bispecific antibody targeting Claudin 18.2, in combination with nivolumab and chemotherapy for HER2-negative metastatic gastric cancer [1][2] Efficacy Results - The study reported an overall response rate (ORR) of 77% (20/26) at the 8 mg/kg dose and 73% (19/26) at the 12 mg/kg dose, confirming previous positive signals [2][6] - The median progression-free survival (PFS) was 16.9 months for the 8 mg/kg cohort, while the 12 mg/kg cohort is still immature with a shorter follow-up [6][12] - A six-month landmark PFS rate was 73% for the 8 mg/kg cohort and 91% for the 12 mg/kg cohort [6][12] Safety Profile - The safety profile of the combination therapy was comparable to existing treatments, with the emergence of immune-related gastritis noted, which correlated with improved clinical outcomes [2][5][18] - Common treatment-related adverse events (TRAEs) included fatigue, nausea, and neutropenia, with low-grade gastritis observed in 33% of patients [18] Market Potential - Givastomig is positioned as a potential best-in-class therapy for gastric cancer, with a projected market opportunity of $12 billion by 2030 [2][5] - The company plans to initiate a global, randomized Phase 2 study to further evaluate both doses against standard care in Q1 2026 [6] Development Context - Givastomig is being developed in partnership with ABL Bio, focusing on Claudin 18.2-positive tumors, and aims to address significant unmet medical needs in gastric cancer [16][17]