1 While research has shown that patients with recurrent disease have worse clinical outcomes than patients with de novo metastatic disease, patients diagnosed with de novo metastatic disease also often progress in less than two years. In the first-line HER2 positive metastatic breast cancer setting, approximately 50% of cases are considered de novo, meaning the disease is metastatic from initial diagnosis, while the remaining cases occur due to disease progression from early stage disease. 4 Approximately one in five cases of breast cancer are considered HER2 positive. HER2 overexpression may be associated with a specific HER2 gene alteration known as HER2 amplification and is often associated with aggressive disease and poor prognosis in breast cancer. HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancers. 3 More than two million cases of breast cancer are diagnosed each year, resulting in nearly 685,000 deaths globally. For more information about the trial, visit .īreast cancer remains the most common cancer and is one of the leading causes of cancer-related deaths in women worldwide. Secondary endpoints include investigator-assessed PFS overall survival (OS) objective response rate duration of response time to second progression or death health-related quality of life (QoL) time to deterioration of physical and role function, global health status/QoL and pain scores generation of antibodies against ENHERTU or pertuzumab immunogenicity pharmacokinetics and safety.ĭESTINY-Breast09 will enroll approximately 1,134 patients at multiple sites in Africa, Asia, Europe, North America, Oceania and South America. The primary endpoint of DESTINY-Breast09 is progression-free survival (PFS) as assessed by blinded independent central review. Randomization will be stratified by prior treatment ( de novo versus recurrent with de novo capped at 50%), hormone receptor (HR) status and PIK3CA mutation status.
Patients will be randomized 1:1:1 to receive either ENHERTU as a monotherapy with a pertuzumab‑matching placebo ENHERTU in combination with pertuzumab or, current THP standard of care (a taxane, trastuzumab and pertuzumab). “Based on the encouraging results we are seeing in patients who have received prior treatment for HER2 positive metastatic breast cancer, we have initiated DESTINY-Breast09 to evaluate whether earlier use of ENHERTU alone or as part of a novel combination regimen may help improve outcomes for patients in the first-line metastatic setting as compared to the current standard of care.”ĭESTINY-Breast09 is a global head-to-head phase 3 trial evaluating the safety and efficacy of ENHERTU (5.4 mg/kg) with or without pertuzumab compared to standard of care (THP: taxane, trastuzumab and pertuzumab) as a first-line treatment in patients with HER2 positive metastatic breast cancer. “There have been no significant advances in first-line metastatic breast cancer treatment in nearly a decade, and most patients still progress on the current standard of care THP regimen, highlighting the need for more effective HER2 directed treatments and novel combination regimens,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. 1 While there have been substantial advances in the treatment of these patients, there remains an ongoing need to improve outcomes, and as a result more effective HER2 directed treatments and novel combination regimens are needed. 1 Research has also shown that patients often progress in less than two years following initial treatment for HER2 positive metastatic breast cancer. Many patients with HER2 positive metastatic breast cancer have aggressive disease due to progression from an earlier stage, with a significant proportion having their disease relapse after receiving THP or other standard anti-HER2 therapies in an adjuvant setting. This is the first trial to evaluate ENHERTU in the first-line metastatic setting in patients with HER2 positive breast cancer. TOKYO & MUNICH, Germany & BASKING RIDGE, N.J.-( BUSINESS WIRE)-Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced that the first patient was dosed in DESTINY‑Breast09, a global head-to-head phase 3 trial evaluating the safety and efficacy of ENHERTU ® (trastuzumab deruxtecan) with or without pertuzumab compared to standard of care (THP: taxane, trastuzumab and pertuzumab) as a potential first-line treatment in patients with HER2 positive metastatic breast cancer.
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