By Fineline Cube 
China-based firms Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) announced the completion of the first interim analysis of the Phase II/III trial (KN026-001) for KN026, a bispecific antibody (BsAb) targeting HER2. The trial is evaluating KN026 in combination with chemotherapy for second-line and above treatment of HER2+ gastric cancer, including adenocarcinoma of the gastroesophageal junction. The study has achieved the predetermined primary endpoint of progression-free survival (PFS), with both statistical and clinical significance, as evaluated by the Independent Data Monitoring Committee (IDMC).
Licensing Agreement and Collaboration
CSPC Pharma’s subsidiary, Shanghai JMT Biotechnology Co., Ltd, entered into a licensing deal with Alphamab in August 2021. The agreement granted exclusive development and commercialization rights to KN026 for breast cancer and gastric cancer indications in mainland China.
Interim Analysis Results
The interim analysis results of the randomized, multi-center Phase II/III study showed that the KN026/chemo combination significantly improved patients’ PFS compared to existing standard treatments. The combination also reduced the risk of disease progression or death and demonstrated a trend toward overall survival (OS) benefit. The study assessed the efficacy of the KN026/chemo combo in HER2+ advanced, unresectable, or metastatic gastric cancer (including gastric esophageal junction adenocarcinoma) after first-line treatment failure.-Fineline Info & Tech