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(Alliance News) - AstraZeneca PLC said on Monday phase three trials for Enhertu showed positive outcomes in metastatic breast cancer patients and could "redefine how the disease is classified and treated".
The Cambridge, England-based pharmaceutical company said Destiny-Breast04 phase three trials had shown Enhertu showed a "statistically significant and clinically meaningful improvement" when compared to chemotherapy in both progress-free survival and overall survival in patients with low human epidermal growth factor receptor 2 unresectable and, or metastatic breast cancer, regardless of their hormone receptor status.
Enhertu, or generically trastuzumab deruxtecan, is a HER2-directed antibody drug conjugate under joint development by Astra and Daiichi Sankyo Co Ltd.
HER2 testing helps to establish appropriate treatment for metastatic breast cancer patients. Patients in the trial were tested for their HER2 status, and defined as HER2-low if they had an immunohistochemistry score of 1+ or 2+ with a negative in-situ hybridisation score. This classification expanded the level of HER2 expression that is eligible for HER2-targeted therapy.
"Targeting the lower range of HER2 expression may offer another approach to delay disease progression and extend survival in patients with metastatic breast cancer," Astra said.
Executive Vice President, Oncology Research & Development Susan Galbraith 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."
AstraZeneca's share price was up 1.4% to 8,926.00 pence each in London on Monday morning.
By Elizabeth Winter; elizabethwinter@alliancenews.com
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