Baili Tianheng has made a significant announcement: its independently developed, globally pioneering EGFR×HER3 bispecific ADC drug, iza-bren—the sole medication to have advanced to the Phase III clinical stage—has successfully met both primary endpoints, namely progression-free survival (PFS) and overall survival (OS), in the interim analysis of a Phase III clinical trial focused on esophageal squamous cell carcinoma. This determination was made by an independent data monitoring committee. The drug is specifically indicated for the treatment of recurrent or metastatic esophageal squamous cell carcinoma in patients who have not responded to prior treatment regimens combining PD-1/PD-L1 monoclonal antibodies with platinum-based chemotherapy. This study marks a historic milestone as it is the world's inaugural Phase III clinical investigation in which an ADC drug has demonstrated positive outcomes for both PFS and OS in the management of esophageal cancer.
