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]

Core Insights - Genmab A/S announced positive results from the Phase 3 EPCORE® FL-1 study, demonstrating that the combination of EPKINLY® (epcoritamab) with rituximab and lenalidomide significantly reduces the risk of disease progression or death by 79% compared to standard care [2][3] - The overall response rate (ORR) for patients treated with EPKINLY + R2 was 95%, compared to 79% for those receiving R2 alone, indicating a substantial improvement in treatment efficacy [2][3] - The U.S. FDA has approved the EPKINLY + R2 combination for patients with relapsed or refractory follicular lymphoma after one or more lines of systemic therapy, marking a significant advancement in treatment options [4][5] Study Results - The EPCORE FL-1 study included patients with relapsed or refractory follicular lymphoma, showing that 83% of patients achieved a complete response (CR) with EPKINLY + R2, compared to 50% with R2 alone [3][5] - The duration of response (DOR) at 12 months was 89% for EPKINLY + R2 versus 49% for R2, highlighting the long-term benefits of the new treatment [3][5] - The safety profile of EPKINLY + R2 was consistent with known safety profiles, with 90.1% of patients experiencing Grade 3 or 4 treatment-emergent adverse events (TEAEs) [3][4] Industry Context - Follicular lymphoma is a common form of non-Hodgkin lymphoma, accounting for 20-30% of all NHL cases, with approximately 15,000 new diagnoses in the U.S. annually [7] - Current standard treatments are often ineffective over time, leading to relapses and shorter remission periods, which underscores the need for innovative therapies like EPKINLY [7] - Epcoritamab, developed using Genmab's DuoBody technology, is designed to target both T cells and B cells, enhancing the immune response against cancer cells [8][9] Future Developments - Genmab and AbbVie are continuing to explore the use of epcoritamab in various hematologic malignancies, with multiple ongoing Phase 3 trials assessing its efficacy as a monotherapy and in combination with other treatments [9] - The companies aim to expand regulatory approvals for epcoritamab in additional indications, including relapsed/refractory diffuse large B-cell lymphoma (DLBCL) [8][9] - Genmab's vision is to transform cancer treatment through innovative antibody medicines, with a focus on improving patient outcomes [10]