By a News Reporter-Staff News Editor at Women's Health Weekly Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced the initiation of DESTINY-Breast01, a pivotal phase 2 study evaluating the safety and efficacy of investigational HER2-targeting antibody drug conjugate (ADC) DS-8201 in patients with HER2-positive unresectable and/or metastatic breast cancer resistant or refractory to ado-trastuzumab emtansine (T-DM1) (see also Pharmaceutical Companies).
About one in five patients with breast cancer overexpress HER2, a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells, which is associated with aggressive disease.1 Many tumors advance to the point where no currently approved HER2-targeting treatment continues to control the disease. Furthermore, there is no current standard of care for HER2-positive tumors after treatment with trastuzumab, pertuzumab and T-DM1.2
"The initiation of this phase 2 study represents an important next step to rapidly advance the development of DS-8201, as we will obtain a better understanding of how the smart delivery of chemotherapy directly to targeted cancer cells may help patients with HER2-expressing metastatic breast cancer," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "In addition to this pivotal study, we will continue to evaluate DS-8201 in other HER2-expressing cancers as well as in combination with other therapies where science suggests that it may help improve patient outcomes."
DESTINY-Breast01 is a pivotal phase 2, open-label, global, multicenter, two-part study evaluating the safety and efficacy of DS-8201 in patients with HER2-positive unresectable and/or metastatic breast cancer resistant or refractory to T-DM1. The primary endpoint of the study is objective response rate. Secondary objectives include duration of response, disease control rate, clinical benefit rate, progression-free survival and overall survival. The first part of the study will include a pharmacokinetic stage and a dose finding stage to identify the recommended dose of DS-8201 to be evaluated in the second part of the study. The second part of the study will enroll patients into one of two cohorts: patients resistant or refractory to T-DM1 (part 2a) and patients who discontinued treatment with T-DM1 for reasons other than resistant or refractory disease (part 2b). DESTINY-Breast01 is expected to enroll more than 230 patients at up to 90 sites in North America, Europe, Japan and other countries in Asia. For more information about this clinical trial, please visit ClinicalTrials.gov.
Keywords for this news article include: Pharmaceutical Companies, Oncology, Breast Cancer, Women's Health, Daiichi Sankyo Company Limited.
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