Core Viewpoint - The interim analysis of the KN026 clinical trial indicates that KN026 combined with chemotherapy shows clinically meaningful and statistically significant benefits in progression-free survival (PFS) and overall survival (OS) compared to placebo combined with chemotherapy, suggesting it as a potential new treatment option for HER2+GC/GEJ patients who have progressed after prior trastuzumab-based therapy [2]. Group 1: Clinical Trial Details - The KN026-001 trial, a Phase III clinical study, involves HER2+GC/GEJ patients who progressed after trastuzumab-based treatment, randomized to receive either KN026 combined with chemotherapy or placebo combined with chemotherapy [1]. - Baseline characteristics of both patient groups were balanced, with a median age of approximately 64 years for the KN026 group and 61 years for the control group, and over 80% of patients in both groups having an ECOG PS score of 1 [1]. Group 2: Mechanism and Future Trials - KN026 is designed to be a next-generation HER2-targeted therapy, capable of binding to two different clinically validated HER2 epitopes while retaining the wild-type Fc region, allowing for dual blockade of HER2-related signaling pathways and enhanced tumor-killing effects [2]. - Multiple Phase III clinical trials are currently underway in China, including studies of KN026 combined with docetaxel for first-line treatment of HER2+ breast cancer and for second-line treatment of HER2+GC/GEJ [2].
康宁杰瑞制药-B(09966.HK)：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