Datroway becomes the first and only therapy to show overall survival benefit versus chemotherapy in this difficult-to-treat patient population
AstraZeneca and Daiichi Sankyo announced positive high-level results from the Phase III TROPION-Breast02 trial evaluating Datroway (datopotamab deruxtecan) in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) who are not eligible for immunotherapy. The trial met both dual primary endpoints, demonstrating statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) compared to investigator’s choice of chemotherapy as 1st-line treatment.
Approximately 70 per cent of patients with metastatic TNBC are not candidates for immunotherapy, including those whose tumours do not express PD-L1, as well as patients with PD-L1-positive tumours who cannot receive immunotherapy due to other factors. For these patients, chemotherapy remains the current 1st-line standard of care and is associated with limited benefit and poor prognosis.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: 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 who cannot receive immunotherapy. These results mark an inflection point in the treatment of this aggressive disease and offer hope to patients who have long faced limited options and poor outcomes.
Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: Datroway is the first antibody drug conjugate – and the only therapy – to significantly improve overall survival compared to chemotherapy in patients with metastatic triple-negative breast cancer who are not eligible for immunotherapy. These landmark results reinforce our confidence in Datroway’s potential across tumour types, and we look forward to engaging with global regulatory authorities to bring this innovative therapy to patients as soon as possible.
The safety profile of Datroway in TROPION-Breast02 was consistent with previous clinical studies in breast cancer. Detailed results will be presented at an upcoming medical meeting and shared with health authorities worldwide.
Datroway (datopotamab deruxtecan) is a specifically engineered TROP2-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.