DATROWAY® Gains EU Approval for Previously Treated Metastatic HR-Positive, HER2-Negative Breast Cancer
Tuesday, April 08, 2025
DATROWAY® (datopotamab deruxtecan) has received approval in the European Union (EU) for use in adults with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer. This applies to patients who have already received endocrine therapy and at least one line of chemotherapy for advanced disease.
DATROWAY is a TROP2-directed DXd antibody drug conjugate (ADC) developed by Daiichi Sankyo and jointly developed and marketed with AstraZeneca.
The European Commission’s approval is based on findings from the phase 3 TROPION-Breast01 trial and follows a positive recommendation from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
In the clinical trial, DATROWAY reduced the risk of disease progression or death by 37% compared to standard chemotherapy options selected by the trial investigators. The median progression-free survival was 6.9 months with DATROWAY, compared to 4.9 months with chemotherapy. The confirmed objective response rate was 36% with DATROWAY versus 23% with chemotherapy. Duration of response was also longer at 6.7 months, compared to 5.7 months for chemotherapy.
Final overall survival results showed no significant difference between the two groups. Median overall survival was 18.6 months for patients treated with DATROWAY and 18.3 months for those given chemotherapy. These results may have been affected by additional treatments received later.
The TROPION-Breast01 trial included adult patients with HR-positive, HER2-negative breast cancer that could not be removed surgically or had spread to other parts of the body. Participants had previously been treated with endocrine therapy and at least one chemotherapy regimen and were not considered suitable for further endocrine therapy.
The study was carried out globally and compared intravenous DATROWAY (6 mg/kg every 21 days) with the investigator’s choice of single-agent chemotherapy, which included eribulin, capecitabine, vinorelbine, or gemcitabine. Patients were not allowed to switch between treatment arms during the trial, but physicians could offer other treatments after disease progression or treatment discontinuation.
The main aims of the trial were to assess progression-free survival (PFS) and overall survival (OS), as reviewed by an independent team. Other important outcomes included objective response rate (ORR), duration of response (DoR), disease control rate, time to next treatment, and safety.
A safety review from two clinical studies involving 443 patients showed that Grade 3 or higher adverse events included stomatitis (7.9%), fatigue (4.3%), anaemia (3.2%), increased liver enzymes (AST 2.7%, ALT 1.6%), vomiting (1.6%), nausea (1.4%), urinary tract infection (1.4%), COVID-19 (1.1%), loss of appetite (1.1%), neutropenia (1.1%), and pneumonia (1.1%). Serious adverse events resulting in death were reported in 0.7% of patients and were mainly linked to interstitial lung disease/pneumonitis, breathing difficulties, and sepsis.
Further details from the TROPION-Breast01 trial, including progression-free survival and other key secondary outcomes, were published in the Journal of Clinical Oncology. Overall survival results were presented during a Virtual Plenary session hosted by the European Society for Medical Oncology in February 2025.
Source: businesswire.com
