ANKE BIO(SZ:300009) Ge Long Hui A P P·2025-10-21 00:52Core Viewpoint - Anke Bio announced the presentation of its self-developed biological innovative drug HuA21 at the ESMO annual meeting, showcasing its efficacy in treating HER2-positive advanced gastric/GEJ adenocarcinoma in combination with trastuzumab and chemotherapy [1] Group 1: Study Overview - The study titled "HuA21 combined with trastuzumab and chemotherapy in HER2-positive advanced gastric/GEJ adenocarcinoma: Phase Ib/II dose-escalation and expansion study" was led by researchers from Fudan University and Anhui Medical University [2] - HuA21 is a monoclonal antibody targeting HER2 with a unique amino acid sequence, possessing independent intellectual property rights [2] Group 2: Efficacy and Safety - Early clinical trials indicated that HuA21 demonstrated good safety with no dose-limiting toxicities observed at doses ≤15 mg/kg and significant anti-tumor activity, achieving an objective response rate (ORR) of 63.6% when combined with trastuzumab and chemotherapy [3] - The study enrolled 60 patients with HER2-positive advanced gastric/GEJ adenocarcinoma, using a "3+3" design for dose escalation and expansion [3] - The ORR for the HuA21 (30 mg/kg) group was 80.8%, while the ORR for the HuA21 (20 mg/kg) group was 76.7%, indicating strong anti-tumor activity [4] Group 3: Safety Profile - The overall safety profile was good, with treatment-emergent adverse events (TEAEs) occurring in 100% of the HuA21 (30 mg/kg) group and 96.7% of the HuA21 (20 mg/kg) group, primarily grade 1-2 [4] - Serious adverse events (SAEs) occurred at rates of 6.7% for the HuA21 (30 mg/kg) group and 23.3% for the HuA21 (20 mg/kg) group [4] - Common TEAEs included thrombocytopenia, anemia, neutropenia, leukopenia, and elevated aspartate aminotransferase, all of which were manageable [4] Group 4: Conclusion - The HuA21 (30 mg/kg) group showed a higher ORR of 80.8% compared to the 20 mg/kg group, with a lower incidence of SAEs, supporting the recommendation of 30 mg/kg as the phase III dose for HER2-positive advanced gastric cancer or GEJ cancer [5]