Bristol Myers: Biokin reports ‘positive’ results from Phase 3 study of iza-bren

SystImmune and Bristol Myers (BMY) Squibb announced that SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., reported positive topline results from a pre-specified interim analysis of a Phase III study evaluating izalontamab brengitecan, an EGFRHER3 bispecific antibody-drug conjugate, in patients with unresectable locally advanced or metastatic triple-negative breast cancer whose disease progressed following prior taxane therapy. In the pre-specified interim analysis, topline results showed that iza-bren demonstrated statistically significant and clinically meaningful improvement in both progression-free survival and overall survival compared to chemotherapy of physician’s choice, meeting both dual primary endpoints. This Phase III study represents the third Phase III trial in which iza-bren has achieved its primary endpoint(s). It is the first bispecific ADC in a Phase III study to report dual positive PFS/OS results in the treatment of triple-negative breast cancer.