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DESTINY-Breast03 included an additional endpoint2:

72% risk reduction (mPFS)
Primary endpoint: PFS (BICR)
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)

~83% (ORR)
Secondary endpoint:
confirmed ORR
a (BICR)

ENHERTU: 82.7% confirmed ORR
(n=205/248; 95% CI: 77.4, 87.2)
15.7% CR (n=39) + 66.9% PR (n=166)

T-DM1: 36.1% confirmed ORR
(n=87/241; 95% CI: 30.0, 42.5)
8.3% CR (n=20) + 27.8% PR (n=67)
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.

NCCN CATEGORY 1, Preferred 2L Option—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+ disease3,b

DESTINY-Breast03 included an additional endpoint2:

Secondary endpoints ENHERTU (n=261) T-DM1 (n=263)
mPFS (investigator),
months (95% CI)
25.1 (22.1, NE) 7.2 (6.8, 8.3)
HR: 0.26 (0.20, 0.35)

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, ORR, and PFS (investigator). ORR and mPFS (investigator) were not tested for statistical significance and not powered to show differences between treatment arms.1,2

aAnalysis was performed based on the patients with measurable disease assessed by BICR at baseline (n=248 patients randomized to receive ENHERTU; n=241 for T-DM1).1

bFam-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]). Regimen may also be used as an option for third-line and beyond; the optimal sequence for third-line therapy and beyond is not known.3

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.

NCCN CATEGORY 1, Preferred 2L Option—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+ disease3,b

View the DESTINY-Breast03 trial results in the New England Journal of Medicine (NEJM)

Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer
Cortés J, Kim SB, Chung WP, et al; DESTINY-Breast03 Trial Investigators.
Published on: March 24, 2022

Some data reported in this publication may be different from or not included in the full Prescribing Information for ENHERTU.
Click here for full Prescribing Information, including Boxed WARNINGS, and click here for Medication Guide.

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2L, second line; BICR, blind independent central review; CI, confidence interval; CR, complete response; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; IV, intravenous; mBC, metastatic breast cancer; mPFS, median progression-free survival; NCCN, National Comprehensive Cancer Network; NE, not evaluable; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; Q3W, every 3 weeks; RECIST, Response Evaluation Criteria in Solid Tumors; T-DM1, ado-trastuzumab emtansine.