Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced the interim analysis results of the KN026 combined chemotherapy for HER2+ GC (including GEJ) in a Phase III clinical trial, showing significant clinical benefits compared to the control group [1][2]. Group 1: Clinical Trial Results - The interim analysis demonstrated that KN026 combined chemotherapy achieved clinically meaningful and statistically significant benefits in progression-free survival (PFS) and overall survival (OS) compared to the placebo group [2]. - The median follow-up time for the Anlotinib group was 9.7 months, while the control group had a median follow-up of 9.8 months [2]. Group 2: Patient Characteristics - The baseline characteristics of patients in both groups were generally balanced, with a median age of approximately 64 years in the Anlotinib group and 61 years in the control group [1]. - Over 80% of patients in both groups had an ECOG PS score of 1, and nearly all patients were diagnosed with stage IVB disease at enrollment [1]. Group 3: Mechanism of Action - KN026 aims to be a next-generation HER2-targeted therapy, capable of dual binding to two clinically validated HER2 epitopes (epitopes II and IV) while retaining the wild-type Fc region [2]. - This mechanism allows KN026 to dual-block HER2-related signaling pathways, enhance binding to HER2 receptors, reduce surface HER2 protein, and improve tumor-killing effects through complete antibody-dependent cellular cytotoxicity [2]. Group 4: Ongoing Clinical Trials - Multiple Phase III clinical trials are currently underway in China, including KN026 combined with docetaxel for first-line treatment of HER2+ breast cancer, and KN026 combined chemotherapy for second-line and above treatment of HER2+ GC/GEJ [3].
康宁杰瑞制药-B(09966)：KN026的III期临床试验的最新研究成果于2025年ESMO大会以LBA口头报告形式呈列