Core Insights - The 2025 World Lung Cancer Conference (WCLC) in Barcelona focuses on advancements in lung cancer research, clinical diagnosis, and innovative therapies, serving as a key platform for global lung cancer treatment innovation [1] Group 1: Clinical Trial Overview - The key registration trial for the drug Aido Tini (TY-9591) by company Same Source Pharmaceutical-B (02410) was selected for a Mini Oral presentation at WCLC 2025, highlighting its significance in the field [1] - The trial is an open-label, multi-center, randomized controlled phase II study targeting NSCLC patients with EGFR mutations (L858R or 19Del) and brain metastases, comparing the efficacy and safety of Aido Tini (160mg daily) against Osimertinib (80mg daily) [2] Group 2: Efficacy Results - As of February 28, 2025, the study enrolled 257 patients, with a mid-term analysis of 224 patients showing an intracranial objective response rate (iORR) of 92.8% for Aido Tini compared to 76.1% for Osimertinib, with a statistically significant P-value of 0.0006 [2] - Investigator-assessed iORR for Aido Tini was 91.0% versus 75.2% for Osimertinib, with a P-value of 0.002, indicating strong efficacy [3] Group 3: Safety Profile - The incidence of grade ≥3 treatment-related adverse events was 31.5% for Aido Tini and 15.0% for Osimertinib, with common severe adverse reactions including elevated creatine phosphokinase and QTc interval prolongation [3] - The incidence of interstitial lung disease (ILD) was 6.3% and QTc prolongation was 4.5%, both within manageable limits [3] Group 4: Market Potential - Currently, there are no approved third-generation EGFR-TKIs for NSCLC with brain metastases, positioning Aido Tini as a promising candidate to meet the clinical needs of this patient population [4] - The recognition of Aido Tini's efficacy and safety data at an international academic conference underscores its potential for clinical translation and commercial success in a supportive policy environment for innovative drug development in China [4]
艾多替尼关键注册Ⅱ期临床成果获选WCLC口头报告，同源康医药-B(02410)差异化创新价值获国际学界认可