Core Viewpoint - The company, Tongyuan Kang Pharmaceutical-B, announced that its innovative drug, Aiduotini Tablets (TY-9591), has been accepted for a mini oral report at the 2025 World Lung Cancer Conference, highlighting its potential in treating EGFR-mutant non-small cell lung cancer (NSCLC) with brain metastases [1][2]. Group 1 - Aiduotini Tablets (TY-9591) is a highly selective small molecule inhibitor targeting classic EGFR gene mutations, aimed at addressing unmet clinical needs in NSCLC patients with brain metastases [1][2]. - 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) versus Osimertinib (80mg once daily) [2]. - The primary endpoints of the study include intracranial objective response rate (iORR) and intracranial progression-free survival (iPFS), with secondary endpoints including overall response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), depth of tumor response (DepOR), and safety indicators [2]. Group 2 - As of February 28, 2025, a total of 257 patients with EGFR-mutant NSCLC and brain metastases were enrolled in the study, with interim analysis based on 224 subjects showing an iORR of 91.9% in the Aiduotini group compared to 76.1% in the Osimertinib group [3]. - The investigator-assessed iORR was 91.0% for Aiduotini and 75.2% for Osimertinib, indicating statistically significant differences (P=0.001 for iORR and P=0.002 for investigator assessment) [3]. - The study led by Professor Shi Yuankai across 51 centers in the country demonstrates that Aiduotini shows superior efficacy in controlling brain metastases and alleviating symptoms, potentially providing a new and more effective first-line treatment option for EGFR-mutant NSCLC patients with brain metastases [3].
同源康医药-B(02410)：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