Innovent Biologics Inc. has announced the initiation of a pivotal Phase 3 clinical study, HeriCare-Breast01, evaluating IBI354—a HER2 monoclonal antibody-camptothecin derivative conjugate (HER2 ADC)—as a first-line treatment for patients with unresectable locally advanced or metastatic HER2-positive breast cancer. The first participant has been successfully dosed in this study in China. IBI354 is also being investigated in another ongoing pivotal Phase 3 trial, HeriCare-Ovarian01. Early-stage studies have demonstrated a favorable safety and efficacy profile for IBI354, but the results of the current Phase 3 trial have not yet been presented and are anticipated in the future.
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