October 19, 2025. Leads & Copy — Positive results from the TROPION-Breast02 phase 3 trial showed DATROWAY® (datopotamab deruxtecan) 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 first-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.
Confirmed objective response rate (ORR) was 62.5% with DATROWAY, including 29 complete responses (CR) and 173 partial responses (PR) versus 29.3% with chemotherapy, including eight CRs and 86 PRs. Median duration of response (DoR) for patients treated with DATROWAY exceeded one year (12.3 months) versus 7.1 months for those treated with chemotherapy.
These late-breaking results will be presented today during a proffered paper session (LBA21) at the 2025 European Society for Medical Oncology (#ESMO25) Congress.
DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo said, “The TROPION-Breast02 results show DATROWAY has the potential to replace traditional chemotherapy in this setting and to meaningfully improve survival of patients.”
Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology 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 first-line setting that can both delay the progression of their disease and prolong their lives,”
Rebecca Dent, MD, FRCP, Professor and Deputy Chief Executive Officer, National Cancer Centre Singapore, and Principal Investigator for the trial.
Contact: www.daiichisankyo.com.
Source: Daiichi Sankyo
