Objective Response Rate Reaches 80.8%: 

AnkeBio’s Novel HuA21 Delivers Breakthrough Data at ESMO 2025

At the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, AnkeBio presented promising Phase Ib/II data for its proprietary Class 1 innovative drug, HuA21 injection. The study, led by Professor Tianshu Liu of Zhongshan Hospital, Fudan University, and Professor Beicheng Sun of the First Affiliated Hospital of Anhui Medical University, evaluated HuA21 in combination with trastuzumab and XELOX chemotherapy as first-line treatment for HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma.

Interim results demonstrated robust antitumor activity and a favorable safety profile. The 30 mg/kg dose cohort achieved an objective response rate (ORR) of 80.8% and a disease control rate (DCR) of 96.3%, while the 20 mg/kg cohort showed an ORR of 76.7% and a DCR of 100%, highlighting the regimen’s potential in this setting.

HuA21 (recombinant humanized anti-HER2 monoclonal antibody injection) is independently developed by AnkeBio. It features a unique amino acid sequence distinct from trastuzumab and pertuzumab and acts through a differentiated mechanism—targeting HER2 domain II to block heterodimerization and synergize with trastuzumab. Preclinical studies suggest a lower cardiotoxicity risk.

The Phase Ib/II dose-escalation and expansion trial enrolled 60 first-line patients as of February 20, 2025. Key results assessed by an independent image evaluation committee (IRRC) are summarized below:

Efficacy

Safety

Both doses were well tolerated. The majority of treatment-emergent adverse events (TEAEs) were grade 1–2, commonly including thrombocytopenia, anemia, neutropenia, leukopenia, and elevated aspartate aminotransferase. The 30 mg/kg group exhibited an even more manageable safety profile, with no unexpected safety signals. Based on an improved benefit–risk profile, the 30 mg/kg dose is recommended for the upcoming Phase III trial.

This first public disclosure of HuA21 clinical data at ESMO marks a significant milestone for Anke Bio in oncology innovation. The company remains committed to advancing HuA21’s clinical development, exploring its potential across additional HER2-positive tumors, and working to bring a valuable new treatment option to patients worldwide.

Disclaimer

1.This news is intended to share scientific updates for healthcare professionals’ reference only and is not for advertising purposes.

2.AnkeBio does not make any recommendation regarding any drug and/or indication.