AstraZeneca reported promising results from a Phase III trial showed Enhertu (trastuzumab deruxtecan) increased progression-free survival and overall survival in patients with certain types of breast cancer.
Enhertu is a HER2-directed antibody-drug conjugate jointly developed by AstraZeneca and Daiichi Sankyo.
Susan Galbraith, executive vice president, oncology R&D, AstraZeneca said: “Today’s historic news from DESTINY-Breast04 could reshape how breast cancer is classified and treated. A HER2-directed therapy has never before shown a benefit in patients with HER2-low metastatic breast cancer. These results for Enhertu are a huge step forward and could potentially expand our ability to target the full spectrum of HER2 expression, validating the need to change the way we categorize and treat breast cancer.”
Ken Takeshita, global head, R&D, Daiichi Sankyo said: “Enhertu continues to redefine the treatment of HER2-targetable cancers. DESTINY-Breast04 is the first-ever Phase III trial of a HER2-directed therapy in patients with HER2-low metastatic breast cancer to show statistically significant and clinically meaningful benefit in progression-free and overall survival compared to standard treatment. We look forward to sharing the detailed findings of DESTINY-Breast04 with the medical community and initiating discussions with regulatory agencies globally with the goal of bringing Enhertu to patients with metastatic breast cancer previously considered to be HER2-negative.”
The data will be presented at a forthcoming medical meeting and shared with global health authorities.
Enhertu is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial.
Enhertu is being further assessed in a comprehensive clinical development program across multiple HER2-targetable cancers, including breast, gastric, lung, and colorectal cancers.
Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide. More than two million cases of breast cancer were diagnosed in 2020 resulting in nearly 685,000 deaths globally.
AstraZeneca employs about 1,500 in Delaware.
