百利天恒核心产品iza-bren三阴乳腺癌Ⅲ期临床达到双主要终点

Core Viewpoint - Sichuan Baili Tianheng Pharmaceutical Co., Ltd. has announced significant progress in its core product, iza-bren (EGFR×HER3 bispecific antibody ADC), achieving dual primary endpoints in a Phase III clinical trial for locally advanced or metastatic triple-negative breast cancer [1] Group 1 - The independent data monitoring committee (iDMC) recommended early submission based on existing results and regulatory communication, while continuing to follow up with participants [1] - Top-line data indicates that iza-bren significantly extends progression-free survival (PFS) and overall survival (OS) for patients with inoperable locally advanced or metastatic triple-negative breast cancer who have previously failed taxane treatment [1] - This Phase III clinical study is the third to achieve primary endpoints for the bispecific antibody ADC and is the first globally to report dual positive results for PFS/OS in triple-negative breast cancer treatment [1] Group 2 - Iza-bren has seven indications included in the breakthrough therapy list by the National Medical Products Administration (NMPA) and has received a similar designation from the U.S. FDA [2] - Two marketing applications for treating nasopharyngeal carcinoma and esophageal squamous cell carcinoma have been accepted and prioritized by the NMPA's Center for Drug Evaluation (CDE) [2]