Partners AstraZeneca (AZ) and Daiichi Sankyo have reported Phase III TROPION-Breast02 results showing TROP2 antibody-drug conjugate (ADC) Datroway (datopotamab deruxtecan) achieved statistically significant overall survival (OS) improvement versus chemotherapy in first-line triple negative breast cancer (TNBC) patients ineligible for immunotherapy. The DXd-platform conjugate also demonstrated highly significant progression-free survival (PFS) benefit with safety profile consistent with previous breast cancer studies. Datroway becomes the first therapy showing survival advantage in this population representing approximately 70% of metastatic TNBC cases, where chemotherapy remains standard care.

TNBC accounts for 15% of global breast cancer cases with median OS of 12 to 18 months in metastatic setting. Datroway's topoisomerase I inhibitor payload delivery through TROP2-targeting addresses high antigen expression in aggressive subtypes. The partners are evaluating combinations with durvalumab in neoadjuvant and metastatic settings through TROPION-Breast03, Breast04 and Breast05 trials. Datroway holds accelerated approval in EGFR-mutant non-small cell lung cancer (NSCLC) and full approval in HR-positive HER2-negative breast cancer across thirty-five markets.

According to PharmCube's NextBiopharm® database, Datroway is under development for several oncology indications in Phase II stage and later alone. Click here to request a free trial for NextBiopharm®.