For US healthcare professionals.
Updated analysis (July 2022)

28.8 months mPFS observed with ENHERTU (6.8 with T-DM1)

72% risk reduction (mPFS)
Initial analysis of mPFS (primary endpoint; May 2021 data cutoff)1,3
72% reduction in risk of disease
progression or death vs T-DM1

(HR: 0.28;
95% CI: 0.22, 0.37; P<0.0001)

ENHERTU: Not Reached mPFS
(95% CI: 18.5, NE)

T-DM1: 6.8 months mPFS
(95% CI: 5.6, 8.2)
Indication

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either:

  • In the metastatic setting, or
  • In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy

Please click here for full Prescribing Information, including Boxed WARNINGS, and click here for Medication Guide.

THE ONLY NCCN CATEGORY 1, Preferred Option in 2L HER2+ mBC
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommends fam-trastuzumab deruxtecan-nxki (ENHERTU) as Category 1 preferred option as second-line therapy for recurrent unresectable (local or regional) or stage IV HER2+ disease5,a

Updated analysis (July 2022)

28.8 months mPFS observed with ENHERTU (6.8 with T-DM1)

  • ENHERTU delivered 28.8 (95% CI: 22.4, 37.9) months mPFS; 6.8 (95% CI: 5.6, 8.2) with T-DM1 (HR: 0.33; 95% CI: 0.26, 0.43)
  • Updated exploratory PFS analysis was not tested for statistical significance and not powered to show differences between treatment arms

DESTINY-Breast03 is a Phase 3, multicenter, open-label, randomized, head-to-head study to compare efficacy and safety of ENHERTU vs T-DM1 of 524 adults with HER2+ unresectable and/or mBC who received prior trastuzumab and taxane therapy for metastatic disease or developed disease recurrence during or within 6 months of completing adjuvant therapy. ENHERTU patients received 5.4 mg/kg IV Q3W until unacceptable toxicity or disease progression. Primary endpoint was PFS (BICR) according to RECIST v1.1. Secondary endpoints included OS and ORR. The FDA has not reviewed the updated analysis for mPFS, mOS, and ORR.1,3

aFam-trastuzumab deruxtecan-nxki may be considered in the first-line metastatic setting as an option for select patients (ie, those with rapid progression within 6 months of neoadjuvant or adjuvant therapy [12 months for pertuzumab-containing regimens]).5

Indication

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either:

  • In the metastatic setting, or
  • In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy

Please click here for full Prescribing Information, including Boxed WARNINGS, and click here for Medication Guide.

THE ONLY NCCN CATEGORY 1, Preferred Option in 2L HER2+ mBC
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommends fam-trastuzumab deruxtecan-nxki (ENHERTU) as Category 1 preferred option as second-line therapy for recurrent unresectable (local or regional) or stage IV HER2+ disease5,a

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2L, second line; BICR, blind independent central review; CI, confidence interval; FDA, Food and Drug Administration; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; IV, intravenous; mBC, metastatic breast cancer; mOS, median overall survival; mPFS, median progression-free survival; NCCN, National Comprehensive Cancer Network; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; Q3W, every 3 weeks; RECIST, Response Evaluation Criteria in Solid Tumors; T-DM1, ado-trastuzumab emtansine.