NovaBridge Doses First Patient in Global, Randomized Phase 2 Study of Givastomig Combined with Immunochemotherapy in Patients with 1L Metastatic Gastric Cancer

Core Insights - NovaBridge Biosciences has initiated a global Phase 2 randomized study for givastomig, a bispecific antibody targeting Claudin 18.2, in combination with nivolumab and chemotherapy for HER2-negative metastatic gastric cancer [1][2][3] - The Phase 1b results demonstrated a 75% objective response rate (ORR) and a median progression-free survival (mPFS) of 16.9 months, indicating strong efficacy and potential for givastomig to become a best-in-class therapy [3][4][5] - The gastric cancer market is projected to reach $12 billion by 2030, highlighting significant commercial potential for givastomig [1][3] Study Details - The Phase 2 study will enroll approximately 180 patients and aims to confirm the efficacy and safety of givastomig in a broader patient population [5] - Primary endpoint is progression-free survival (PFS), with secondary endpoints including ORR, overall survival (OS), duration of response (DoR), and disease control rate (DCR) [5] Clinical Data - Phase 1b data showed that patients treated with givastomig at 8 mg/kg and 12 mg/kg had an ORR of 77% and 73% respectively, with durable responses and good tolerability [4][3] - The study's results are expected to be presented in 2027, with updated Phase 1b results anticipated in the second half of 2026 [2][3] Product Overview - Givastomig is designed to activate T cells in the tumor microenvironment, targeting Claudin 18.2-positive tumor cells, and is being developed for gastric and other gastrointestinal cancers [7][11] - The product is being developed in partnership with ABL Bio, with NovaBridge holding worldwide rights outside of Greater China and South Korea [8]