Datopotamab Deruxtecan Demonstrates Improvement in Progression-Free Survival in HR+, HER2- Breast Cancer


Datopotamab deruxtecan (Dato-DXd; AstraZeneca, Daiichi Sankyo) also demonstrated improved overall survival compared to chemotherapy.

Datopotamab deruxtecan (Dato-DXd; AstraZeneca, Daiichi Sankyo) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy of choice in a study of patients with inoperable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-low or negative breast cancer previously treated with endocrine-based therapy and at least 1 systemic therapy.1 Datopotamab deruxtecan is a DXd antibody drug conjugate specifically engineered to be directed at TROP2.1

Doctor examines mammogram snapshot of breast of female patient on the monitors | Image Credit: okrasiuk - stock.adobe.com

okrasiuk - stock.adobe.com

“[The] TROPION-Breast01 news is a significant development for patients with HR-positive, HER2-low or negative metastatic breast cancer whose tumors have become insensitive to endocrine therapy and who currently face poor outcomes. We are encouraged by these positive results,” Susan Galbraith, PhD, executive vice president of Oncology Research and Development at AstraZeneca said in a statement.1

According to the CDC, in the United States, breast cancer is the second most common cancer among women, with more Black women dying from the disease than White women.2

The global, randomized trial compared datopotamab deruxteca to the investigator’s choice of single-agent chemotherapy, including eribulin, capecitabine, vinorelbine, or gemcitabine. The dual primary endpoints were PFS, as evaluated by a blinded independent central review, and OS. The key secondary endpoints included objective response rate, duration of response, investigator-assessed PFS, disease control rate, and time to first subsequent therapy, according to the statement.1

More than 700 patients were included from Asia, Europe, North America, South America, and Africa.1

The drug demonstrated improved overall survival (OS) compared to chemotherapy; however, the data were not mature at the time of the interim analysis of the TROPION-Breast01 trial (NCT05104866), which will continue to assess OS.1

The interim results also demonstrated a consistent safety profile for the drug, previously found in other clinical trials in the same patient population. There were no new safety signals identified, and all grade interstitial lung disease rates were low.

The data are planned to be presented at an upcoming medical meeting and shared with health authorities.1

“The positive topline results from TROPION-Breast01 demonstrate the potential for datopotamab deruxtecan to become an important treatment option for patients with HR-positive, HER2-low, or HER2-negative breast cancer in the second-line metastatic setting. We look forward to realizing the full potential of this TROP2-directed antibody drug conjugate across breast cancer subtypes through our ongoing phase 3 program, including 2 trials in patients with triple-negative breast cancer,” Ken Takeshita, MD, global head of Oncology Research and Development at Daiichi Sankyo, said in the statement.1

The companies have 2 additional phase 3 trials planned to evaluate datopotamab deruxtecan in breast cancer. TROPION-Breast02 (NCT05374512) will compare the drug to chemotherapy in patients with previously untreated, locally recurrent inoperable or metastatic triple-negative breast cancer and who are not candidates for anti-programmed death-ligand 1 therapy. TROPION-Breast03 (NCT05629585) will evaluate datopotamab deruxtecan with and without durvalumab (Imfinzi; AstraZeneca) compared to the investigators’ choice of therapy for patients with stage 1 through 3 triple-negative breast cancer with residual disease after neoadjuvant therapy.1


  1. Datopotamab deruxtecan demonstrated statistically significant and clinically meaningful progression-free survival benefit in patients with HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial. News release. AstraZeneca. September 22, 2023. Accessed September 22, 2023. https://www.astrazeneca.com/media-centre/press-releases/2023/dato-dxd-improved-pfs-in-breast-cancer.html
  2. Centers for Disease Control and Prevention. Breast Cancer: Statistics. Updated June 8, 2023. Accessed September 22, 2023. https://www.cdc.gov/cancer/breast/statistics/index.htm
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