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Enhertu trial results show significant improvement for breast cancer patients

The treatment, jointly developed by AstraZenca and Daiichi Sankyo, was trialled in the pivotal DESTINY-Breast04 study


AstraZeneca (AZ) and Daiichi Sankyo have shared positive results from the pivotal DESTINY-Breast04 trial, assessing the jointly developed metastatic breast cancer treatment, Enhertu (trastuzumab deruxtecan).

DESTINY-Breast04 is a global, randomised phase 3 trial evaluating the safety and effectiveness of Enhertu that has enrolled approximately 540 patients in Europe, North America and Asia. All patients taking part in the trial were given an HER2 test and the results were centrally confirmed.

Breast cancer is one of the leading causes of cancer-related deaths globally, with more than two millions cases diagnosed in 2020, resulting in nearly 685,000 deaths worldwide.

HER testing is well established in determining the right treatment pathway for patients with metastatic breast cancer. As another approach to delaying disease progression, targeting the lower range of HER2 expression also has the potential to extend survival for patients living with metastatic breast cancer.

At present, chemotherapy is the only available treatment option for patients with HR-positive tumours following progression on hormone therapy and for patients who are HR-negative.

The trial showed that the treatment offered both a statistically and clinically significant improvement in progression-free survival and overall survival in patients diagnosed with HER2-low unresectable and/or metastatic breast cancer.

Commenting on the developments, Susan Galbraith, executive vice president of Oncology R&D at AZ 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 categorise and treat breast cancer.”

Ken Takeshita, global head of R&D at Daiichi Sankyo, said: “DESTINY-Breast04 is the first ever phase 3 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.”

Takeshita added: “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.”

Enhertu is receiving further evaluation in a clinical development programme to assess effectiveness and safety across multiple HER2-targetable cancers, including gastric, lung, breast and colorectal cancers.

Article by
Fleur Jeffries

21st February 2022

From: Research



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