BIOKIN's EGFR×HER3 Bispecific ADC Iza-bren Meets Primary Endpoints in Phase III Trial for Advanced Triple-Negative Breast Cancer

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Sichuan Biokin Pharmaceutical Co., Ltd. (688506.SH) announced that an interim analysis of the Phase III clinical trial for iza-bren, an EGFR×HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic triple-negative breast cancer has met its primary endpoints. The Independent Data Monitoring Committee (iDMC) for the Phase III study recommended, based on the interim analysis results, to communicate with regulatory authorities for early submission while continuing patient follow-up. Topline data indicated that iza-bren significantly prolonged both progression-free survival (PFS) and overall survival (OS), achieving the dual primary endpoints. The indication is for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer that has failed prior taxane therapy. This marks the third Phase III clinical study in which this bispecific ADC has met its primary endpoints, and it is the first global Phase III study of a bispecific ADC to demonstrate positive PFS and OS outcomes in triple-negative breast cancer (Study Protocol Number: BL-B01D1-307).

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