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NovaBridge Highlights Phase 1b Givastomig Combination Results With Strong Responses And Manageable Safety In First-Line Gastric Cancer

Benzinga · 2d ago
  • Givastomig, a CLDN18.2 x 4-1BB bispecific antibody, continues to show robust efficacy when combined with nivolumab and chemotherapy (mFOLFOX6) in 1L HER2-negative, metastatic gastric cancer patients, with 77% ORR observed at 8 mg/kg and 73% ORR observed at 12 mg/kg, across a wide range of PD-L1 and CLDN18.2 expression levels
  • The median PFS was 16.9 months at 8 mg/kg; 12 mg/kg is immature with approximately 4-month shorter median follow-up; data will be updated in 2026
  • Six-month landmark PFS was 73% for 8 mg/kg, and 91% for 12 mg/kg cohorts
  • Combination was well tolerated; safety is comparable to the current standard of care treatment
  • Data demonstrate that givastomig is a potential best-in-class CLDN18.2 asset when added to 1L standard of care
  • NovaBridge is on track to initiate enrollment in a global, randomized Phase 2 study, evaluating both doses against standard of care, in Q1 2026
  • Detailed Phase 1b dose expansion data are expected to be presented at a medical conference later in 2026