I-Mab filed a 6-K disclosing Exhibit 99.1 from NovaBridge Biosciences announcing the first patient dosed in a global, randomized Phase 2 study of givastomig combined with immunochemotherapy in 1L HER2-negative metastatic gastric cancer patients. Topline Phase 2 results are expected in 2027, building on Phase 1b data showing 75% ORR and 16.9-month mPFS.
Key takeaways
NovaBridge dosed first patient in global randomized Phase 2 study of givastomig (8 mg/kg and 12 mg/kg) + nivolumab + mFOLFOX6 in 1L HER2-negative metastatic gastric cancer
Phase 1b results: 75% ORR (77% at 8 mg/kg, 73% at 12 mg/kg, n=52), 16.9-month mPFS, 82% 6-month PFS (n=53)
Phase 2 to enroll ~180 patients globally with CLDN18.2 ≥1+ IHC on ≥1% cells and PD-L1 ≥1, primary endpoint PFS