AstraZeneca And Daiichi Sankyo Report Positive Phase III Results For Datroway; Shows OS And PFS Benefit In Phase III TROPION-Breast02 In TNBC

AstraZeneca and Daiichi Sankyo announced positive top-line results from the Phase III TROPION-Breast02 trial, demonstrating that Datroway (datopotamab deruxtecan) significantly improved both overall survival (OS) and progression-free survival (PFS) versus investigator’s choice of chemotherapy. The study evaluated Datroway as a first-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) who were not eligible for immunotherapy.

Susan Galbraith, Executive Vice President, Oncology Haematology 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 for whom immunotherapy is not an option. We expect today’s results will mark an inflection point in the treatment of these patients who have the poorest prognosis of any type of breast cancer and urgently need better options.”

An estimated 70% of metastatic TNBC patients are ineligible for immunotherapy, including those with PD-L1–negative tumors and others unable to receive such treatments due to medical constraints. For this large patient population, chemotherapy remains the current standard of care, underscoring the potential of Datroway as a transformative first-line option.

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 for whom immunotherapy is not an option. These landmark results from TROPION-Breast02 strengthen our confidence in our ongoing clinical development programme for Datroway in triple-negative breast cancer and other tumour types. We look forward to discussing these data with global regulatory authorities and to bringing Datroway to patients with triple-negative breast cancer as soon as possible.”

The safety profile of Datroway was consistent with previous breast cancer studies, and detailed results will be presented at an upcoming medical conference and submitted to regulatory authorities. Datroway is a TROP2-directed DXd antibody-drug conjugate (ADC) developed by Daiichi Sankyo and jointly commercialized with AstraZeneca. The companies are continuing to evaluate Datroway in three additional Phase III trials, TROPION-Breast03, -Breast04, and -Breast05, which explore its role across earlier-stage and PD–L1–positive TNBC settings.