Daiichi Sankyo Introduces First-of-its-kind ENHERTU® for Metastatic Breast Cancer
Daiichi Sankyo has introduced ENHERTU®, a groundbreaking treatment option for certain patients with HER2 low or HER2 ultralow metastatic breast cancer.
ENHERTU is a leading antibody-drug conjugate (ADC) in oncology portfolio, designed using proprietary DXd ADC technology. It combines a HER2 monoclonal antibody with topoisomerase I inhibitor payloads (an exatecan derivative, DXd) linked by tetrapeptide-based cleavable linkers.
ENHERTU is specifically indicated for adult patients with:
- Unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen in either the metastatic setting or in the neoadjuvant or adjuvant setting and have experienced disease recurrence during or within six months of completing therapy.
- Unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have previously undergone chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
- Unresectable or metastatic non-small cell lung cancer (NSCLC) with activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have previously received systemic therapy.
The ongoing DESTINY-Breast06 trial is a global, randomised, open-label, phase 3 study that assesses the efficacy and safety of ENHERTU (5.4 mg/kg) compared to the investigator’s choice of chemotherapy (capecitabine, paclitaxel, or nab-paclitaxel) in patients with HR-positive, HER2-low, or HER2-ultralow advanced or metastatic breast cancer.
Participants had no prior chemotherapy for advanced or metastatic disease and had received at least two lines of endocrine therapy in the metastatic setting.
Eligibility also extended to those who had one prior line of endocrine therapy combined with a CDK4/6 inhibitor in the metastatic setting and experienced disease progression within six months of starting first-line treatment or who had received endocrine therapy as an adjuvant treatment and experienced disease recurrence within 24 months.
If approved, ENHERTU has the potential to redefine the treatment landscape, extending the reach of HER2-directed therapies to a broader group of patients.
