AstraZeneca and Daiichi Sankyo’s Datroway Outperforms Chemotherapy in First-Line TNBC

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC), Datroway (datopotamab deruxtecan), has shown superior efficacy over chemotherapy in immunotherapy-ineligible metastatic triple-negative breast cancer (TNBC). In the Phase III TROPION-Breast02 trial (NCT05374512), Datroway met its co-primary endpoints by significantly improving overall survival (OS) and progression-free survival (PFS) compared with standard chemotherapy. The Trop2-targeting ADC demonstrated a safety profile consistent with previous studies, with common adverse events including stomatitis, fatigue, and decreased leukocyte counts.

Currently, chemotherapy is the mainstay for TNBC patients lacking estrogen, progesterone, and HER2 receptors, who are ineligible for immunotherapy. Regulatory discussions are planned to expand Datroway’s label, adding to its existing approvals in second-line breast cancer and third-line non-small cell lung cancer. Analysts forecast blockbuster potential, projecting $3.1 billion in 2031 sales, surpassing the Trop2-targeting competitor Trodelvy, which is largely limited to later-line therapy. Datroway could redefine treatment for first-line TNBC patients.

06-10-2025