AstraZeneca and Daiichi Sankyo Announce Dato-DXd Meets Dual Primary Endpoints in Phase III TROPION-Breast02 Trial as First-Line Treatment for Immune-Ineligible Triple-Negative Breast Cancer

▎Armstrong

On October 6, 2025, AstraZeneca/Daiichi-Sankyo announced that the Phase III clinical trial TROPION-Breast02 of the new Trop2 ADC drug Dato-DXd for first-line treatment of triple-negative breast cancer (TNBC) achieved dual endpoints of OS and PFS. This Phase III clinical trial targeted TNBC populations unsuitable for immunotherapy, including PD-L1 negative populations and those expressing PD-L1 but unsuitable for immunotherapy, which account for 70% of the TNBC population.

AstraZeneca/Daiichi-Sankyo is also conducting a phase I-III clinical trial of Dato-DXd ± PD-L1 antibody as neoadjuvant therapy for TNBC, a phase II-III clinical trial of Dato-DXd combination as neoadjuvant therapy for TNBC or HR-/HER2 low-expression or HER2-negative breast cancer, and a phase III clinical trial of Dato-DXd ± PD-L1 antibody as first-line treatment for PD-L1-positive TNBC.

AstraZeneca has made a comprehensive layout around lung cancer, breast cancer, etc. Taking breast cancer as an example, HER2-positive breast cancer is mainly treated with HER2 ADC, HR+ breast cancer is mainly treated with HER2 ADC, CDK4/6 inhibitors, SERD, etc., and TNBC is mainly treated with Trop2 ADC.

Summary

In recent years, there have been significant advances in the field of triple-negative breast cancer (TNBC). Immunotherapy has become the standard first-line treatment for PD-L1 expressing TNBC. This time, Dato-DXd has successfully extended its coverage to the first-line treatment of a broader population unsuitable for immunotherapy and expanded its use to include first-line treatment of PD-L1 positive patients through combination with PD-L1. In addition, BioNTech's PD-L1/VEGF has shown excellent efficacy in both first-line and second-line TNBC.

Including the first-line TNBC and first-line SCLC trials conducted in China, as well as three global Phase III clinical trials for first-line SCLC, first-line NSCLC, and the newly initiatedFirst-line TNBC,。