By Fineline Cube 
Alphamab Oncology (HKG: 9966) today disclosed the first interim data from its Phase III study evaluating anbenitamab injection (KN026), in combination with chemotherapy, as a second‑line and beyond treatment for HER2‑positive gastric cancer, including gastro‑oesophageal junction adenocarcinoma. The results were presented at the European Society for Medical Oncology (ESMO) Congress 2025.
Study Highlights
| Endpoint | Anbenitamab + Chemo | Control (Chemo + Placebo) | Hazard Ratio (HR) | P‑value |
|---|---|---|---|---|
| Median Progression‑Free Survival (PFS) | 7.1 mo | 2.7 mo | 0.25 | 5.44 × 10⁻¹² |
| Median Overall Survival (OS) | 19.6 mo* | 11.5 mo | 0.29 | 1.56 × 10⁻⁶ |
| Objective Response Rate (ORR) | 55.8 % | 10.8 % | — | — |
| Disease‑Control Rate (DCR) | 80.0 % | 41.9 % | — | — |
| Median Duration of Response (DoR) | 8.2 mo | 2.9 mo | — | — |
*OS data are immature.
Statistical Impact – The anbenitamab cohort experienced a 75 % reduction in the risk of disease progression or death (HR 0.25) and a 71 % reduction in the risk of death (HR 0.29) compared with control, with highly significant P‑values (P < 0.00001).
Product & Development Profile
- Anbenitamab (KN026) – A HER2 bispecific antibody engineered on Alphamab’s proprietary Fc heterodimer platform (CRIB).
- Mechanism – Simultaneous binding to two non‑overlapping HER2 epitopes, blocking downstream HER2 signaling.
- Collaborators – Developed in partnership with Shanghai JMT Biotechnology Co., Ltd., a wholly‑owned subsidiary of CSPC Pharmaceutical Group.
- Regulatory Milestone – In September 2025, the NMPA accepted the first New Drug Application (NDA) for anbenitamab for HER2‑positive gastric cancer.
Market Implications
- Competitive Edge – The interim data position anbenitamab as a compelling second‑line therapy in a high‑need, high‑mortality patient population.
- Strategic Expansion – Successful outcomes will support global launch plans and potential expansion into other HER2‑positive malignancies.
- Investor Interest – The robust clinical results and regulatory acceptance are expected to enhance Alphamab’s valuation and attract additional partnership opportunities.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech