Sichuan Biokin Pharmaceutical (688506.SH): Iza-bren (EGFRHER3 bispecific ADC) achieved the primary endpoint in the phase III trial of locally advanced or metastatic triple-negative breast cancer.

Sichuan Biokin Pharmaceutical (688506.SH) disclosed an announcement regarding the interim analysis of the Phase III clinical trial of Iza-bren (EGFRHER3 bispecific ADC) for locally advanced or metastatic triple negative breast cancer. The independent Data Monitoring Committee (iDMC) recommended in the preset interim analysis that, "Based on the current analysis results, communicate with regulatory authorities for early reporting and continue follow-up with subjects." Topline data showed that Iza-bren significantly prolonged progression-free survival (PFS) and overall survival (OS), meeting both primary endpoints. The indication is for the treatment of unresectable locally advanced or metastatic triple negative breast cancer that has failed prior taxane treatment. This is the third Phase III clinical trial where the bispecific ADC has met primary endpoints, and is the first global Phase III clinical trial where a bispecific ADC drug has achieved positive results for both PFS and OS in the treatment of triple negative breast cancer (study protocol number: BL-B01D1-307).