Daiichi Sankyo's TROP2 ADC Datopotamab Deruxtecan Receives First Global Approval in Japan for HR+/HER2- Metastatic Breast Cancer

On December 27, Daiichi Sankyo announced its TROP-2 ADC product Datopotamab deruxtecan(Dato-DXd, Deda Botu Monoclonal Antibody, Trade Name: Datroway)Approved for Marketing in Japan, for the treatment of hormone receptor (HR) positive, HER2 negative(IHC 0, IHC 1+, or IHC 2+/ISH-)Adult patients with breast cancer who have undergone chemotherapy and have unresectable or recurrent disease.

Dato-DXd isJapan's FirstThe TROP-2 ADC drug approved for the treatment of HR-positive, HER2-negative breast cancer is alsoThe Second Approval Based on Daiichi Sankyo's DXd-ADC TechnologyADC drugs.

The drug, co-developed by Daiichi Sankyo and AstraZeneca, has been approved in the United States.(NSCLC, HR+/HER2- breast cancer), EU(NSCLC, HR+/HER2- breast cancer), China(HR+/HER2- Breast Cancer)Submit for market approval.

Source: Daiichi Sankyo Official Website

This approval is based on the pivotal Phase III clinical TROPION-Breast01 study data.

TROPION-Breast01 Study is Dato-DXdThe First Published Phase III Clinical Trial Results for Breast Cancer, aimed to evaluate Dato-DXd versus investigator-selected chemotherapy regimens in patients with unresectable or metastatic HR-positive, HER2-low or negative who have previously received endocrine therapy and at least one systemic therapy.(IHC 0, IHC 1+, or IHC 2+/ISH-)Efficacy and Safety in Breast Cancer. The primary endpoints are PFS and OS assessed by BICR.

The results of the study, presented at the 2023 ESMO Congress, showed that in terms of the primary endpoint PFS, assessed by BICR, compared with investigator-selected chemotherapy（ICC）In comparison, Dato-DXd is used for HR-positive, HER2-negative metastatic breast cancer patients who have undergone endocrine therapy.Can significantly reduce the risk of disease progression or death by 37%（HR = 0.63；95% CI: 0.52-0.76；p<0.0001）。

Dato-DXd Treatment GroupMedian PFS was 6.9 months, while the chemotherapy group was 4.9 months. Consistent PFS benefits were observed across different subgroups. Additionally, the Dato-DXd group showedORR was 36.4%, while the chemotherapy group was 22.9%. In the interim analysis of the study's other primary endpoint, OS, as of the data cutoff date, Dato-DXd also demonstrated a trend towards superior OS improvement compared to chemotherapy.（HR = 0.84；95% CI: 0.62-1.14）。

In terms of safety, Dato-DXd demonstrated an overall good safety profile, with no new safety issues identified. The incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 21% in the Dato-DXd group and 45% in the chemotherapy group, with the Dato-DXd group showing less than half the rate of the chemotherapy group.

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