Berlin, Germany — October 19, 2025 — Leads & Copy — Positive results from the TROPION-Breast02 Phase III trial showed DATROWAY® (datopotamab deruxtecan-dlnk) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator’s choice of chemotherapy as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option.
DATROWAY demonstrated a 5.0-month improvement in median OS compared to chemotherapy (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0291). Median OS was 23.7 months for patients treated with DATROWAY versus 18.7 months for those treated with chemotherapy.
DATROWAY reduced the risk of disease progression or death by 43% compared to chemotherapy (HR 0.57; 95% CI 0.47-0.69; p<0.0001) as assessed by blinded independent central review (BICR). Median PFS was 10.8 months for patients treated with DATROWAY versus 5.6 months for those treated with chemotherapy.
These late-breaking results were presented today during a Proffered Paper session at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany (abstract #LBA21).
Rebecca Dent, MD, FRCP, Professor and Deputy Chief Executive Officer, National Cancer Centre Singapore, and principal investigator for the trial, said: “In TROPION-Breast02, datopotamab deruxtecan meaningfully extended patients’ lives and nearly doubled their time without disease progression. These are significant outcomes for patients with metastatic triple-negative breast cancer who are not suitable candidates for immunotherapy, and remarkable results considering the trial included a subset of patients with highly aggressive disease who are often excluded from research in this setting.”
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “The TROPION-Breast02 results show for the first time that these triple-negative breast cancer patients may have an alternative to chemotherapy in the 1st-line setting that can both delay the progression of their disease and prolong their lives. For Datroway to have so significantly improved patient outcomes in the 1st-line metastatic setting as monotherapy also gives us great confidence in its potential in combination with IMFINZI® (durvalumab), and in the early-stage, potentially curative setting where our next studies are ongoing.”
Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “Patients with metastatic triple-negative breast cancer have one of the worst prognoses of any breast cancer subtype, and for those who are not candidates for immunotherapy, chemotherapy has long been the 1st-line standard of care. The TROPION-Breast02 results show Datroway has the potential to replace traditional chemotherapy in this setting and to meaningfully improve survival of patients.”
DATROWAY is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
AstraZeneca and Daiichi Sankyo will also present updated results from the BEGONIA Phase Ib/II trial at ESMO showing DATROWAY in combination with IMFINZI continued to demonstrate robust anti-tumor activity as 1st-line treatment for patients with metastatic TNBC across PD-L1 expression levels and specifically in those with high PD-L1-expressing tumors. These results will be presented on Monday, October 20 (abstract #555MO).
AstraZeneca and Daiichi Sankyo are evaluating DATROWAY across stages and treatment settings of TNBC in three additional Phase III trials. TROPION-Breast03 is evaluating DATROWAY with or without IMFINZI in patients with Stage I-III TNBC with residual invasive disease after neoadjuvant systemic therapy. TROPION-Breast04 is evaluating neoadjuvant DATROWAY plus IMFINZI in patients with Stage II-III triple-negative or hormone receptor (HR)-low, HER2-low or -negative breast cancer. TROPION-Breast05 is evaluating 1st-line DATROWAY with or without IMFINZI in patients with metastatic TNBC whose tumors express PD-L1.
Rebecca Dent, MD, FRCP, Professor and Deputy Chief Executive Officer, National Cancer Centre Singapore, and principal investigator for the trial.
Source: AstraZeneca
