Core Viewpoint - The company, Baillie Gifford, announced that its self-developed first-in-class EGFR×HER3 dual antibody ADC (iza-bren) has achieved dual primary endpoints of progression-free survival (PFS) and overall survival (OS) in a Phase III clinical trial for esophageal squamous cell carcinoma [1] Group 1: Clinical Trial Results - Iza-bren is the first ADC drug to achieve positive results for both PFS and OS in a Phase III clinical study for esophageal cancer [1] - The trial targets patients with recurrent or metastatic esophageal squamous cell carcinoma who have previously failed treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy [1] Group 2: Regulatory Status - Iza-bren is currently undergoing over 40 clinical trials in China and the United States for various tumor types [1] - Seven indications for iza-bren have been included in the breakthrough therapy list by the National Medical Products Administration in China, and one indication has been recognized by the U.S. Food and Drug Administration as a breakthrough therapy [1]
百利天恒:iza-bren用于复发性或转移性食管鳞癌的III期临床试验的期中分析达到主要终点