Alphamab oncology's KN026 shows significant benefits in gastric cancer trial

Alphamab Oncology has announced positive interim results from a Phase III clinical trial of KN026, co-developed with Shanghai JMT-Bio Technology Co., Ltd., for HER2+ gastric cancer (GC) and gastroesophageal junction (GEJ) cancer. The trial, designated KN026-001 (KC-WISE), demonstrated clinically meaningful and statistically significant benefits when KN026 was combined with chemotherapy as a second-line or above treatment. These findings were presented at the ESMO Congress 2025 LBA Oral Presentation Session.

Key efficacy data from the interim analysis, assessed by an Independent Review Committee (IRC), shows a median PFS of 7.1 months for the Anbenitamab Group versus 2.7 months for the Control Group, representing a 75% reduction in the risk of disease progression or death (HR 0.25, P value 5.44 × 10–12). The median OS for the Anbenitamab Group was 19.6 months (not mature) compared to 11.5 months in the Control Group, indicating a 71% reduction in the risk of death (HR 0.29, P value 1.56 × 10-6).

The objective response rate (ORR) was 55.8% for the Anbenitamab Group against 10.8% for the Control Group, with a disease control rate (DCR) of 80.0% and 41.9%, respectively. The median duration of response (DoR) was 8.2 months versus 2.9 months. The safety profile was favorable and manageable, with the incidence of grade 3 or above treatment-emergent adverse events (TEAEs) at 60.6% in the Anbenitamab Group and 51.6% in the Control Group.