DATROWAY

AstraZeneca and Daiichi Sankyo’s DATROWAY met dual primary endpoints in the TROPION-Breast02 Phase III trial for locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) patients. DATROWAY demonstrated a statistically significant and clinically meaningful improvement in both overall survival (OS) and progression-free survival (PFS) versus chemotherapy. The trial showed a 43% reduction in disease progression or death risk and a 5-month improvement in median OS versus chemotherapy. Detailed results will be presented at the 2025 ESMO Congress.

The TROPION-Breast02 phase 3 trial, presented at ESMO 2025, shows DATROWAY significantly improved overall survival (OS) and progression-free survival (PFS) versus chemotherapy in locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) patients ineligible for immunotherapy. DATROWAY reduced the risk of disease progression or death by 43% and improved median OS by 5 months. The objective response rate was 62.5% with DATROWAY versus 29.3% with chemotherapy, and median duration of response was 12.3 versus 7.1 months, respectively.

The TROPION-Lung02 and TROPION-Lung04 trials support DATROWAY (datopotamab deruxtecan) combined with immunotherapy as a first-line treatment for advanced NSCLC. TROPION-Lung02 showed a 54.8% objective response rate with DATROWAY and pembrolizumab. Exploratory analyses show promising biomarker associations and the TROPION-Lung04 study found a 57.5% objective response rate when using DATROWAY with rilvegostomig. NeoCOAST-2 data also revealed positive results in the neoadjuvant setting.