Sichuan Biokin Pharmaceutical (688506.SH): The interim analysis of the Phase III clinical trial of iza-bren for recurrent or metastatic esophageal squamous cell carcinoma has reached the primary endpoint.

Sichuan Biokin Pharmaceutical (688506.SH) announced that its globally pioneering, new concept, and only EGFRHER3 bispecific ADC (iza-bren) has achieved both progression-free survival (PFS) and overall survival (OS) endpoints in the Phase III clinical trial for esophageal squamous cell carcinoma (study protocol number: BL-B01D1-305), as judged by the independent data monitoring committee (iDMC) at the pre-specified interim analysis. The indication is for recurrent or metastatic esophageal squamous cell carcinoma that has previously failed treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy. This is the first Phase III clinical trial in the world to demonstrate positive results for both PFS and OS in esophageal cancer treatment with an ADC drug. Iza-bren is the only EGFRHER3 bispecific ADC that is globally pioneering, a new concept, and has entered the Phase III clinical stage. Iza-bren is undergoing more than 40 clinical trials in China and the United States targeting a variety of tumor types. As of now, iza-bren has been included in the breakthrough therapy drug list by the National Medical Products Administration Drug Evaluation Center for 7 indications, and by the U.S. Food and Drug Administration for 1 indication.