and Daiichi Sankyo Co.
on Monday reported positive Phase 3 trial results for the Enhertu treatment on breast cancer patients.
The pharmaceutical companies said Enhertu demonstrated meaningful survival improvement in patients with breast cancer compared with physician’s choice of chemotherapy.
“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,” Susan Galbraith, AstraZeneca’s executive vice president for Oncology R&D, said.
The HER2 protein is expressed on the surface of many types of tumors, and is one of many biomarkers expressed in breast cancer tumors.
“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,” she said.
“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 potentially bringing Enhertu to patients with metastatic breast cancer previously considered to be HER2 negative,” Ken Takeshita, global head of R&D at Daiichi Sankyo, said.
The Destiny-Breast04 trial enrolled around 540 patients in Asia, Europe and North America. AstraZeneca and Daiichi Sankyo have a 50/50 development and commercialization agreement for Enhertu.
Shares in AstraZeneca at 0856 GMT were up 1.5% at 8,934 pence.
Write to Jaime Llinares Taboada at email@example.com; @JaimeLlinaresT