Based on DESTINY-Breast09 phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s ENHERTU in combination with pertuzumab significantly improved progression-free survival versus current first-line standard of care in HER2 positive metastatic breast cancer
The European Medicines Agency has validated the Type II Variation marketing authorization application for ENHERTU in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer.
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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The application is based on data from the DESTINY-Breast09 phase 3 trial presented during a speciallate-breaking oral session at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting and subsequently published in The New England Journal of Medicine. In the trial, ENHERTU in combination with pertuzumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment for patients with HER2 positive metastatic breast cancer.
“This validation in the EU is an important step in moving us closer to offering ENHERTU in combination with pertuzumab as a potential new first-line treatment option for patients with HER2 positive metastatic breast cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “Following the recent approval in the U.S. for this indication, we look forward to working closely with the EMA to bring ENHERTU to eligible patients in the EU who may benefit from improved outcomes in a setting where the standard of care has not changed in more than a decade.”
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About DESTINY-Breast09
DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as first-line treatment in patients with HER2 positive metastatic breast cancer.
Patients were randomized 1:1:1 to receive either ENHERTU monotherapy with a pertuzumab matching placebo; ENHERTU in combination with pertuzumab; or THP. Randomization was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status.
The primary endpoint of DESTINY-Breast09 is PFS as assessed by blinded independent central review in both the ENHERTU monotherapy and ENHERTU combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, objective response rate, duration of response, pharmacokinetics and safety. The investigational arm assessing ENHERTU monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.
DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America.
About HER2 Positive Metastatic Breast Cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally. In Europe, approximately 557,000 cases of breast cancer are diagnosed annually, with more than 144,000 deaths. While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or that have progressed to metastatic disease are expected to live five years following diagnosis.
HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer. HER2 protein overexpression may occur as a result of HER2 gene amplification.Approximately one in five cases of breast cancer are considered HER2 positive.
HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer. While HER2 targeted therapies have improved outcomes,prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death.
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Source- businesswire
