Daiichi Sankyo Submits New Drug Application in Japan for Dato-DXd as Treatment for HR+/HER2- Metastatic Breast Cancer

Mar 15, 2024 06:30 CST Updated 06:30

Daiichi-Sankyo

Pharmaceutical R&D Developer

On March 14, Daiichi Sankyo announced that it had submitted a marketing application for Dato-DXd in Japan.For the treatment of adult patients with unresectable or metastatic breast cancer that is HR-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) and who have previously received systemic therapy at the unresectable or metastatic disease stage.

Source: Daiichi Sankyo Official Website

Dato-DXd (Datopotamab deruxtecan/Datozumab Deruxtecan) is a TROP2 ADC jointly developed by Daiichi Sankyo and AstraZeneca.

The marketing application submitted this time is based on the pivotal Phase III clinical trial. TROPION-Breast 01 Research data.

TROPION-Breast01The study is the first Phase III clinical trial of Dato-DXd in breast cancer to report results, aiming to evaluate the efficacy and safety of Dato-DXd compared with investigator-selected chemotherapy regimens in patients with unresectable or metastatic HR-positive, HER2-low or negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have previously received endocrine therapy and at least one systemic therapy. 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, as assessed by BICR, Dato-DXd demonstrated superior progression-free survival compared to investigator's choice chemotherapy (ICC) in HR-positive, HER2-negative (IHC0, IHC1+ or IHC2+/ISH-) metastatic breast cancer patients previously treated with 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 ORR in the Dato-DXd group was 36.4%., while the chemotherapy group was 22.9%.

In the interim analysis of the other primary endpoint OS of the study, as of the data cutoff date, Dato-DXd also showed a trend of OS improvement over chemotherapy (HR = 0.84; 95% CI: 0.62-1.14). The study is currently ongoing and will further evaluate OS.

In terms of safetyDato-DXd demonstrated a favorable overall safety profile, with no new safety concerns 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.

InBreast Cancer FieldAccording to the Insight database, Daiichi Sankyo/AstraZeneca have jointly launched 5 Phase III clinical trials, exceptIn addition to HR+/HER2- breast cancer, it also includes first-line therapy and adjuvant therapy for metastatic triple-negative breast cancer, among others.

Beyond breast cancer, progress is also being made inLung CancerProgress in the field. Last month, Daiichi Sankyo announced,Dato-DXd BLA Application Accepted by FDAFor adult patients with locally advanced or metastatic non-squamous NSCLC who have previously received systemic therapy. The PDUFA date is December 20, 2024.Expected to become the world's first TROP ADC for lung cancer treatment.

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