The European Commission (EC) has approved Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) for use as a single agent to treat adults with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) low or ultralow breast cancer.
The approval is for those who have undergone a minimum of one endocrine treatment in the metastatic setting and are deemed unsuitable for further endocrine therapy.
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Following this EU approval, Daiichi Sankyo will receive a milestone payment of $125m from AstraZeneca for the HER2 low and HER2 ultralow chemotherapy-naïve breast cancer indication.
Daiichi Sankyo discovered this HER2-directed antibody-drug conjugate (ADC) and is co-developing and commercialising it along with AstraZeneca. It is tailored leveraging Daiichi’s DXd ADC technology.
The ADC has gained approval based on the Phase III DESTINYBreast06 trial’s outcomes. This follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use.
In DESTINYBreast06, the ADC demonstrated a significant minimisation in the disease progression or mortality risk against chemotherapy in subjects with chemotherapy-naïve HR positive, HER2-low metastatic breast cancer.
866 subjects were enrolled across Oceania, Asia, North America, South America and Europe.
The median progression-free survival for subjects treated with the ADC was 13.2 months versus 8.1 months for those receiving chemotherapy.
The safety profile of Enhertu in the DESTINYBreast06 trial is consistent with previous trials, with no safety concerns observed.
Daiichi Sankyo CEO, president and oncology business global head Ken Keller stated: “Today’s approval expands the use of Enhertu to now include an earlier treatment setting of HER2 low metastatic breast cancer and broadens the patient population eligible for treatment to those with HER2 ultralow disease.”
Enhertu’s approval extends to 75 nations, inclusive of the EU, for individuals with HER2 low metastatic breast cancer who have previously received systemic therapy or experienced disease recurrence shortly after adjuvant chemotherapy.
In October 2023, the EC approved Enhertu for treating advanced non-small cell lung cancer patients with a HER2 mutation.
