AstraZeneca, Daiichi Sankyo's DATROWAY Showed Statistically Significant, Clinically Meaningful Improvement For Dual Primary Endpoints Of Overall Survival, Progression-Free Survival In TROPION-Breast02 Phase 3 Study For Recurrent Inoperable Or Metastatic Triple-negative Breast Cancer

Author: Benzinga Newsdesk | October 29, 2025 07:14am

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.

These late-breaking results will be presented today during a Proffered Paper session at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany (abstract #LBA21).

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.

In addition to patients whose tumors did not express PD-L1, TROPION-Breast02 enrolled patients with PD-L1 expressing tumors for whom immunotherapy was not an option due to other factors.

Posted In: AZN