Core Insights - The company, Tongyuan Kang Pharmaceutical-B (02410.HK), announced that its innovative drug, Aiduotini Tablets (TY-9591), for treating EGFR-mutated non-small cell lung cancer (NSCLC), has had its key Phase II registration clinical trial results accepted for a mini oral report at the 2025 World Lung Cancer Conference (WCLC) [1][2] - Aiduotini Tablets (TY-9591) is a highly selective small molecule inhibitor targeting classic EGFR gene mutations, aimed at addressing unmet clinical needs for brain metastases in NSCLC under current treatment standards [1] Study Details - The ESAONA key trial is an open-label, multi-center, randomized Phase II study focusing on patients with EGFR mutations (L858R or 19Del) and brain metastases, comparing the efficacy and safety of Aiduotini (160mg once daily) against Osimertinib (80mg once daily) in treatment-naive EGFR-sensitive mutation patients with brain metastases [2] - Primary endpoints include intracranial objective response rate (iORR) and intracranial progression-free survival (iPFS), while secondary endpoints encompass overall response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), depth of tumor response (DepOR), and safety indicators [2] - Interim analyses will occur twice: the first when 220 evaluable intracranial lesions are reached, and the second upon reaching 238 iPFS events, with final analysis conducted after all iPFS events are completed [2] - If primary endpoints are met, the first interim analysis data will be used to submit relevant materials to the National Medical Products Administration (NMPA) for conditional market approval, while the final data analysis will support the application for full market approval of Aiduotini Tablets [2]
同源康医药-B(02410.HK)：EGFR靶向创新药艾多替尼在脑转移肺癌患者中展现突破性疗效——WCLC 2025公布ESAONA关键注册研究中期结果