Anhui Anke drug shows promising results in HER2-positive gastric cancer study

Anhui Anke Biotechnology Group will present new clinical study data for its innovative drug, HuA21 injection, at the 2025 European Society for Medical Oncology (ESMO) annual congress. The Phase Ib/II dose-escalation and expansion study evaluated HuA21 in combination with trastuzumab and chemotherapy for HER2-positive advanced gastric/GEJ adenocarcinoma.

The study enrolled 60 patients, with 30 in the HuA21 (20mg/kg) group and 30 in the HuA21 (30mg/kg) group. Independent imaging committee assessments revealed objective response rates (ORR) of 80.8% for the 30 mg/kg group and 76.7% for the 20 mg/kg group, indicating strong anti-tumor activity. Disease control rates (DCR) were 96.2% and 100%, respectively.

Safety data showed HuA21 was well-tolerated, with treatment-emergent adverse events (TEAEs) occurring in 100% (30 mg/kg) and 96.7% (20 mg/kg) of patients, predominantly Grade 1-2. Serious adverse event (SAE) rates were 6.7% and 23.3%. Overall, the treatment regimen displayed favorable efficacy and safety, supporting the 30 mg/kg dose for HER2-positive advanced gastric cancer.