Daiichi Sankyo and AstraZeneca Submit NDA for Dato-DXd in China for HR+/HER2- Metastatic Breast Cancer
Daiichi-Sankyo
Pharmaceutical R&D Developer
AstraZeneca
Biopharmaceutical Manufacturer
On March 16, according to the CDE official website, the marketing application for Dato-DXd submitted by Daiichi Sankyo was accepted.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.
From:CDE Official Website
Dato-DXd (Datopotamab deruxtecan/Datozumab Deruxtecan) is a TROP2 ADC jointly developed by Daiichi Sankyo and AstraZeneca.
The marketing authorization application for Deda Botu Monoclonal Antibody is based on the pivotal Phase III clinical trial. TROPION-Breast 01 Research data.
TROPION-Breast01This study is the first Phase III clinical trial of Dato-DXd in breast cancer to report results, designed to evaluate the efficacy and safety of Dato-DXd compared with investigator-selected chemotherapy 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 efficacy in HR-positive, HER2-negative (IHC0, IHC1+, or IHC2+/ISH-) metastatic breast cancer patients previously treated with endocrine therapy, compared to investigator’s choice chemotherapy (ICC).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 in the study, as of the data cutoff date, Dato-DXd also demonstrated a trend toward superior OS improvement compared to chemotherapy (HR = 0.84; 95% CI: 0.62-1.14). The study is ongoing and will further evaluate OS.
In terms of safetyDato-DXd demonstrated an overall favorable 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 conducted 5 Phase III clinical trials, exceptIn addition to HR+/HER2- breast cancer, it also includes first-line therapy for metastatic triple-negative breast cancer as well as adjuvant therapies, etc.
Beyond breast cancer, progress is also being made inLung CancerProgress in the field. Last month, The two companies jointly 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.
In addition, the efficacy of Dato-DXd in combination with immune checkpoint inhibitors is also being explored. Currently, Daiichi Sankyo/AstraZeneca and Merck are collaborating on three clinical trials—TROPION-Lung02, TROPION-Lung07, and TROPION-Lung08—to evaluate the combination therapy of Dato-DXd and Keytruda.
Among them, the jointly conducted Phase Ib clinical trialTROPION-Lung02 StudyIt is the first study to evaluate the combination of TROP2 ADC and immune checkpoint inhibitors for the treatment of advanced NSCLC patients (with or without platinum-based chemotherapy).The latest results of the TROPION-Lung02 study presented at the 2023 ASCO Annual Meeting show,Dato-DXd Combined with K Medicine(With or without platinumChemotherapy) in previously untreated patients ORR were 57% and 50%, respectively., with a disease control rate of 91% across cohorts.
As forGastric Cancer, Endometrial CancerOther cancer types also launched a Phase II global clinical trial in July 2022 (Registration Number: NCT05489211), with the first global subject enrolled in September of the same year. The primary endpoint is expected to be completed by March 2025.
