Investigational Therapy, Tucatinib, Shows Early Promise for HER2-positive Patients

Investigational Therapy, Tucatinib, Shows Early Promise for HER2-positive Patients
Findings from a Phase 1 clinical trial show that women with heavily treated breast cancer could benefit from the investigational HER2 small molecule inhibitor tucatinib. Despite a median of five prior treatment regimens, more than a quarter of the women saw clinical benefit from the treatment. Based on the findings, the study, which was only meant to assess tucatinib's safety, will now expand into a more elaborate Phase 1b trial. The U.S. Food and Drug Administration (FDA) also granted the treatment fast-track status in June. The study, "Phase 1 Study of ONT-380, a HER2 Inhibitor, in Patients with HER2+ Advanced Solid Tumors, with an Expansion Cohort in HER2+ Metastatic Breast Cancer (MBC)," was published in the journal Clinical Cancer Research. "Usually we expect the results of a phase 1 clinical trial to give us data that we can use to guide the results of future treatments. This is a great case in which, for many of these patients, the results were immediate. There are women who are alive today because of this drug," Virginia Borges, MD, MMSc, director of the Breast Cancer Research Program and Young Women's Breast Cancer Translational Program at the University of Colorado Cancer Center, said in a press release. Tucatinib is a small molecule inhibitor of the HER2 receptor that stops cancers with activating mutations in the HER2 gene from sending abnor
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