Date: 2017-08-29
Type of
information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Daiichi Sankyo (Japan)
Product: DS-8201
Action
mechanism:
- antibody drug conjugate. DS-8201 is an investigational antibody drug conjugate comprised of a humanized anti-HER2 antibody attached by a peptide linker to a novel topoisomerase I inhibitor, utilizing Daiichi Sankyo’s proprietary payload and linker-payload technology. It is currently in phase 1 clinical development for HER2 expressing advanced or metastatic breast cancer or gastric cancer and other HER2 expressing solid cancers.
- The FDA granted Breakthrough Therapy designation to DS-8201 for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1), and Fast Track designation 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 T-DM1.
Disease: HER2-positive unresectable and/or metastatic breast cancer resistant or refractory to ado-trastuzumab emtansine (T-DM1)
Therapeutic
area: Cancer - Oncology
Country: Japan, USA
Trial
details:
- 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). (NCT03248492)
Latest
news:
- • On August 29, 2017, 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).
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.
Is
general: Yes
