EU panel backs Enhertu® for HR-positive, HER2 low or ultralow metastatic breast cancer
The recommendation for Enhertu® is based on positive results from the DESTINY-Breast06 trial, which demonstrated superiority of Enhertu® over chemotherapy.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Enhertu® (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HR-positive, HER2 low or HER2 ultralow breast cancer after at least one line of endocrine therapy.
Breast cancer remains one of the most common and deadly cancers affecting women worldwide, with over 2 million cases diagnosed annually. Among these, hormone receptor (HR) positive, HER2 low and HER2 ultralow metastatic breast cancer subtypes have been challenging to treat effectively.
“Endocrine therapy is typically used in the initial treatment of HR-positive metastatic breast cancer but as the disease progresses the benefit of continued endocrine therapy is limited and subsequent standard of care chemotherapy is associated with poor outcomes,” explains Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca.
Trastuzumab deruxtecan is an antibody-drug conjugate jointly developed by Daiichi Sankyo (Tokyo, Japan) and AstraZeneca (Cambridge, UK). The treatment has already received approval in more than 75 countries for various HER2-expressing cancers, including HER2 low metastatic breast cancer. Now, CHMP is recommending trastuzumab deruxtecan based on positive results from the DESTINY-Breast06 Phase III trial, which highlighted trastuzumab deruxtecan’s superiority over chemotherapy.For patients with chemotherapy-naïve HR-positive, HER2 low metastatic breast cancer, trastuzumab deruxtecan reduced the risk of disease progression or death by 38% compared to chemotherapy. The median progression-free survival observed for trastuzumab deruxtecan was 13.2 months, compared to 8.1 months for chemotherapy.
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Other key findings from the trial include a confirmed objective response rate of 56.5% for HER2 low patients treated with trastuzumab deruxtecan, compared to 32.2% for chemotherapy. The drug also demonstrated a median duration of response of 14.1 months, compared to 8.6 months observed in the chemotherapy arm.
In the broader trial population, including patients with HER2 ultralow expression, trastuzumab deruxtecan showed a 36% reduction in the risk of disease progression or death compared to the chemotherapy arm. The confirmed overall response rate for this population was 57.3%, and the median progression free survival was 13.2 months, compared to 8.1 months for chemotherapy.
“ENHERTU is the first HER2 directed treatment and antibody drug conjugate to show a progression free survival of more than 1 year in patients with HER2 low or HER2 ultralow metastatic breast cancer following endocrine therapy,” explained Ken Takeshita, Global Head of R&D at Daiichi Sankyo.
The safety profile of trastuzumab deruxtecan in the DESTINY-Breast06 trial was consistent with previous studies, with no new safety concerns identified.
The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorization in the EU. If approved, ENHERTU could offer a new standard of care for patients with HR-positive, HER2 low, or HER2 ultralow metastatic breast cancer who have exhausted endocrine therapy options.