For US healthcare professionals.

ENHERTU is the first and only HER2-directed therapy to bring proven survival benefit to patients with HER2-low (IHC 1+ or IHC 2+/ISH–) mBC previously classified as HER2-negative1,2

10.1 months mPFS
Primary endpoint: PFS (BICR) in the HR+/HER2-low mBC cohort ENHERTU nearly doubled mPFS vs chemotherapy1

ENHERTU: 10.1 months mPFS (n=331; 95% CI: 9.5, 11.5) vs Chemotherapy: 5.4 months mPFS (n=163; 95% CI: 4.4, 7.1)

(HR: 0.51; 95% CI: 0.40, 0.64; P<0.0001)

23.9 months mOS Secondary endpoint: OS in the HR+/HER2-low mBC cohort
ENHERTU increased mOS by >6 months vs chemotherapy1

ENHERTU: 23.9 months mOS (n=331; 95% CI: 20.8, 24.8) vs Chemotherapy: 17.5 months mOS (n=163; 95% CI: 15.2, 22.4)
(HR=0.64; 95% CI: 0.48, 0.86; P=0.0028)
Indication

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

  • Unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH‑) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy

ENHERTU has serious Warnings and Precautions. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

ENHERTU is the first and only HER2-directed therapy to bring proven survival benefit to patients with HER2-low (IHC 1+ or IHC 2+/ISH–) mBC previously classified as HER2-negative1,2

DESTINY-Breast04 is a phase 3, international, multicenter, randomized, open-label trial of ENHERTU vs physician’s choice of chemotherapy in 557 patients with HER2-low mBC (IHC 1+ or IHC 2+/ISH–). The study included 2 cohorts: 494 HR+ and 63 HR–. Patients had 1 or 2 prior lines of chemotherapy in the metastatic setting, and if HR+, had also progressed on or were refractory to endocrine therapy. Patients in the ENHERTU arm received 5.4 mg/kg IV Q3W and patients in the chemotherapy arm could receive eribulin, capecitabine, gemcitabine, nab-paclitaxel, or paclitaxel. Treatment was continued until unacceptable toxicity or disease progression. The primary endpoint was PFS in the HR+ population (determined by BICR according to mRECIST v1.1). Select secondary endpoints included PFS (BICR) in the overall study population (HR+ and HR–), OS in the HR+ population, OS in the overall study population (HR+ and HR–), ORR in the HR+ population, and DOR in the HR+ population.1,3

NCCN PREFERRED
National Comprehensive Cancer Network® (NCCN®) CATEGORY 1, Preferred Systemic Therapy Regimen— NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommends fam-trastuzumab deruxtecan-nxki (ENHERTU) as the Category 1 preferred systemic therapy option for recurrent unresectable (local or regional) or stage IV HER2-negative disease, for patients with tumors that are HER2 IHC 1+ or 2+ and ISH negative.4,a National Comprehensive Cancer Network® (NCCN®) CATEGORY 1, Preferred Systemic Therapy Regimen—
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommends fam-trastuzumab deruxtecan-nxki (ENHERTU) as the Category 1 preferred systemic therapy option for recurrent unresectable (local or regional) or stage IV HER2-negative disease, for patients with tumors that are HER2 IHC 1+ or 2+ and ISH negative.4,a

aFor patients with tumors that are HER2 IHC 1+ or 2+ and ISH negative, who have received at least 1 prior
line of chemotherapy for metastatic disease and, if tumor is HR+, are refractory to endocrine therapy.

Indication

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

  • Unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH‑) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy

ENHERTU has serious Warnings and Precautions. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

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BICR, blinded independent central review; CI, confidence interval; DOR, duration of response; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; HR+, hormone receptor-positive; HR–, hormone receptor-negative; IHC, immunohistochemistry; ISH, in situ hybridization; IV, intravenous; mBC, metastatic breast cancer; mOS, median overall survival; mPFS, median progression-free survival; mRECIST, Modified Response Evaluation Criteria in Solid Tumors; NCCN, National Comprehensive Cancer Network; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; Q3W, every 3 weeks.