WILMINGTON, DE — AstraZeneca and Daiichi Sankyo announced that their jointly developed therapy, DATROWAY® (datopotamab deruxtecan-dlnk), achieved positive top-line results in the Phase III TROPION-Breast02 trial, marking a major advancement in the treatment of metastatic triple-negative breast cancer (TNBC).
The study demonstrated that DATROWAY significantly improved both overall survival (OS) and progression-free survival (PFS) compared with investigator’s choice of chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic TNBC who are not eligible for immunotherapy. This is the first therapy to show a statistically significant survival benefit over chemotherapy in this difficult-to-treat population.
Triple-negative breast cancer, one of the most aggressive and lethal breast cancer subtypes, lacks targeted treatment options. Roughly 70% of patients with metastatic TNBC are not candidates for immunotherapy due to the absence of PD-L1 expression or other contraindications, leaving chemotherapy as the primary standard of care.
“TROPION-Breast02 is the only trial ever to show an overall survival benefit in the first-line treatment of patients with metastatic triple-negative breast cancer for whom immunotherapy is not an option,” said Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca. “We expect these results will mark an inflection point in the treatment of these patients who have the poorest prognosis and urgently need better options.”
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, noted that DATROWAY is the first antibody-drug conjugate to demonstrate a significant overall survival advantage compared to chemotherapy in this population. “These landmark results strengthen our confidence in DATROWAY’s potential across tumor types,” he said, adding that the companies plan to discuss the data with regulatory authorities worldwide.
DATROWAY is a specifically engineered, TROP2-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and co-developed with AstraZeneca. The therapy’s safety profile in this trial was consistent with previous studies. Detailed results will be presented at an upcoming medical conference.
Beyond TROPION-Breast02, the companies are conducting three additional Phase III trials evaluating DATROWAY in various stages and treatment settings of TNBC, including early-stage disease and combinations with immunotherapy.
If approved, DATROWAY could redefine the treatment landscape for patients with metastatic TNBC who have long faced limited therapeutic options and poor prognoses.
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