Datroway (datopotamab deruxtecan) is launched in Japan as the first TROP-2 directed therapy for patients with previously treated unresectable or recurrent HR positive, HER2 negative breast cancer- Daiichi Sankyo

Datroway  (datopotamab deruxtecan) has been launched in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy. Datroway is the first ever TROP2 directed medicine to be launched in Japan for HR positive, HER2 negative breast cancer and is the second DXd antibody drug conjugate (ADC) available based on Daiichi Sankyo’s DXd ADC Technology. 

Marketing approval of Datroway was granted by the Japan Ministry of Health, Labour and Welfare (MHLW) in December 2024 based on the results from the TROPION-Breast01 phase III trial where Datroway significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63, 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 6.9 months in patients treated with Datroway compared to 4.9 months in those treated with chemotherapy.

TROPION-Breast01 is a global, randomized, multicenter, open-label phase III trial evaluating the efficacy and safety of intravenous datopotamab deruxtecan (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one prior line of chemotherapy for unresectable or metastatic disease. Following disease progression or discontinuation of datopotamab deruxtecan or chemotherapy, patients had the option to receive a subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted.

The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and overall survival (OS). Key secondary endpoints include overall response rate, duration of response, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in the Journal of Clinical Oncology. The OS data were presented at a Virtual Plenary session hosted by the European Society for Medical Oncology (ESMO) in February 2025.

“HR positive, HER2 negative unresectable or recurrent breast cancer has historically been treated with conventional chemotherapy after progression with hormone therapy, which is associated with poor response rates and a low five-year survival rate,” said Kei Kiuchi, Vice President, Oncology Marketing Department, Japan Business Unit, Daiichi Sankyo. “Patients now will have access to DATROWAY, the first TROP2 directed medicine available in Japan for this specific type of metastatic breast cancer.

See citation- Bardia A, Jhaveri K, Im SA, Pernas S et al. Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor–Positive Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer: Primary Results From TROPION-Breast01.  J Clin Oncol   2024 43, 285 DOI:10.1200/JCO.24.00920