Daiichi Sankyo announced that the Food and Drug Administration (FDA) has granted Fast Track designation for DS-8201 for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine (T-DM1).
DS-8201, an investigational HER2-targeting antibody drug conjugate, consists of a humanized anti-HER2 antibody attached by a peptide linker to a novel topoisomerase I inhibitor that incorporates the Company’s linker-payload technology. This combination allows for higher drug-to-antibody (DAR) ratio of ~8, which may help target low expressing HER2 tumors by supplying greater payload per antibody to a tumor.
DS-8201 is currently in Phase 1 clinical testing for HER2+ advanced or metastatic breast cancer or gastric cancer, HER2 low expressing breast cancer, and other HER2 expressing solid cancers. The second half (dose expansion) of the Phase 1 study is currently enrolling patients to evaluate the safety and efficacy of DS-8201 in four different cohorts of HER2 expressing cancers:
- Patients with HER2+ metastatic breast cancer previously treated with T-DM1
- Patients with HER2+ gastric or gastroesophageal junction adenocarcinoma previously treated with trastuzumab
- Patients with HER2 low expressing breast cancer
- Patients with other solid cancers that express HER2