Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer
Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the DESTINY-Breast04 Phase III trial.
In the trial, Enhertu significantly reduced the risk of disease progression or death by 50% versus physician’s choice of chemotherapy (based on a hazard ratio [HR] of 0.50; 95% confidence interval [CI]: 0.40-0.63; p<0.0001) in patients with HER2-low metastatic breast cancer with hormone receptor (HR)-positive or HR-negative disease. A median progression-free survival (PFS) of 9.9 months was seen with Enhertu versus 5.1 months in those treated with chemotherapy, as assessed by blinded independent central review (BICR). A 36% reduction in the risk of death was seen with Enhertu compared to chemotherapy (hazard ratio of 0.64; 95% CI: 0.49-0.84; p=0.001) with a median overall survival (OS) of 23.4 months versus 16.8 months.
The safety profile observed in patients treated with Enhertu in the DESTINY-Breast04 trial was consistent with that seen in other trials of Enhertu in breast cancer with no new safety signals identified.
Financial arrangements for the product sales between Daiichi Sankyo and AstraZeneca were set out in the March 2019 announcement of the collaboration.
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