Positive Phase II trial results for AZ’s DS-8201

AstraZeneca and Daiichi Sankyo have announced positive top-line results for the DESTINY-Breast01 pivotal Phase II trial, which evaluated the treatment in patients with HER2-positive (around one in five breast cancers are HER2-positive), unresectable and metastatic breast cancer previously treated with trastuzumab emtansine. The antibody drug conjugate DS-8201 (trastuzumab deruxtecan), demonstrated a clinically meaningful response in patients with refractory HER2-positive metastatic breast cancer. Safety and tolerability profiles were found to be consistent with previous experience. It has been given FDA Breakthrough Therapy Designation and Fast Track Designation for HER2-positive patients in the advanced or refractory breast cancer setting.
AZ’s executive vice president of R&D Oncology, José Baselga, said they are “encouraged to see positive data, with the DESTINY-Breast01 trial now reinforcing what earlier data have shown. We believe this antibody drug conjugate has the potential to redefine the treatment of patients with HER2-expressing cancers, and we are eager to bring it as quickly as possible to patients with refractory HER2-positive breast cancer who continue to have high unmet medical need.”