Core Viewpoint - The announcement highlights the promising results of the innovative drug Eltotinib (TY-9591) developed by the company for treating EGFR-mutated non-small cell lung cancer (NSCLC) with brain metastases, which has been accepted for presentation at the 2025 World Lung Cancer Conference [1][2]. Group 1: Clinical Trial Details - The ESAONA trial is an open-label, multi-center, randomized Phase II study focusing on patients with EGFR mutations (L858R or 19Del) and brain metastases, comparing Eltotinib (160mg once daily) with Osimertinib (80mg once daily) [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 be conducted twice, with the first at 220 evaluable intracranial lesions and the second at 238 iPFS events, with final analysis upon reaching all iPFS events [2]. Group 2: Study Results - As of February 28, 2025, the study enrolled 257 patients with EGFR-mutated NSCLC and brain metastases, with interim analysis based on 224 subjects showing an iORR of 91.9% in the Eltotinib group compared to 76.1% in the Osimertinib group (P=0.001) [3]. - Investigator-assessed iORR was 91.0% for Eltotinib versus 75.2% for Osimertinib (P=0.002), and the overall response rate (ORR) was 84.7% for Eltotinib compared to 75.2% for Osimertinib [3]. - The study indicates that Eltotinib demonstrates superior efficacy in controlling brain metastases and alleviating symptoms, potentially offering a new and more effective first-line treatment option for patients with EGFR-mutated NSCLC and brain metastases [3].
同源康医药-B：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