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, indicating significant clinical benefits in progression-free survival (PFS) and overall survival (OS) compared to the control group [1][2]. Group 1: Clinical Trial Results - The interim analysis presented at the 2025 ESMO conference showed that KN026 combined with chemotherapy demonstrated clinically meaningful and statistically significant benefits in PFS and 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+BC, KN026 combined chemotherapy for second-line and above treatment of HER2+GC/GEJ, and KN026 combined with docetaxel for neoadjuvant treatment of BC [3].
康宁杰瑞制药-B：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