HR+ Efficacy Data

Nearly doubled mPFS vs chemotherapy with the first and only HER2-directed therapy for HER2-low mBC1

ENHERTU demonstrated a statistically significant and clinically meaningful PFS benefit in HR+/HER2-low mBC (n=494; primary endpoint, BICR)1,2

KM curve depicting (10.1 months mPFS) with ENHERTU compared to (5.4 months mPFS) with chemotherapy in HR+/HER2-low mBC KM curve depicting (10.1 months mPFS) with ENHERTU compared to (5.4 months mPFS) with chemotherapy in HR+/HER2-low mBC

ENHERTU reduced the risk of disease progression or death by 49% vs chemotherapy (HR=0.51; 95% CI: 0.40, 0.64; P<0.0001)1

PFS benefit was observed with ENHERTU in prespecified exploratory patient subgroups2,3

  • Prespecified exploratory patient subgroups were not tested for statistical significance and not powered to show differences between treatment arms or between subgroups

Subgroups were chosen based on DESTINY-Breast04 stratification factors.

A benefit over chemotherapy was observed in patient subgroups, including in patients with prior CDK4/6 inhibitor treatment2,3

>6 months longer overall survival vs chemotherapy2

ENHERTU significantly increased mOS in HR+/HER2-low mBC (n=494; secondary endpoint)2

KM curve depicting (23.9 months mOS) with ENHERTU compared to (17.5 months mOS) with chemotherapy in HR+/HER2-low mBC KM curve depicting (23.9 months mOS) with ENHERTU compared to (17.5 months mOS) with chemotherapy in HR+/HER2-low mBC
  • Median follow-up: 18.4 months (95% CI: 17.7, 18.9)2

36% reduction in the risk of death vs chemotherapy
(HR=0.64; 95% CI: 0.48, 0.86; P=0.0028)1

More than tripled ORR vs chemotherapy (n=494)1

Over half of patients with HR+/HER2-low mBC who received ENHERTU had a confirmed objective response (secondary endpoint, BICR)1

Bar chart depicting confirmed (52.9% ORR) with ENHERTU and (16.6% ORR) with chemotherapy in HR+/HER2-low. ORR was not tested for statistical significance, and was not powered to show differences between treatment arms Bar chart depicting confirmed (52.9% ORR) with ENHERTU and (16.6% ORR) with chemotherapy in HR+/HER2-low. ORR was not tested for statistical significance, and was not powered to show differences between treatment arms
  • mDOR was 10.7 months with ENHERTU and 6.8 months with chemotherapy1
  • ORR and DOR were not tested for statistical significance, and were not powered to show differences between treatment arms
  • 71.2% CBR (CR + PR + SD>6 months) with ENHERTU (n=237/333) and 34.3% with chemotherapy (n=57/166)2,a

Nearly 90% (n=293/333) of patients experienced disease control (CR+PR+SD) with ENHERTU2,a,b

NCCN GUIDELINES® PREFERRED

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Preferred

NCCN CATEGORY 1, Preferred Systemic Therapy Regimen
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommends fam-trastuzumab deruxtecan-nxki (ENHERTU) as a Category 1, preferred second-line systemic therapy option for recurrent unresectable (local or regional) or stage IV HER2-negative breast cancer in4,c:

  • Patients with HR+ disease who are in visceral crisis or are endocrine refractory with tumors that are HER2 IHC 1+ or 2+ and ISH negative
  • Patients with HR– disease who have tumors that are HER2 IHC 1+ or 2+ and ISH negative with no germline BRCA1/2 mutation

aHormone receptor status is based on data from the electronic data capture.2

bDCR was 66.3% with chemotherapy (n=110/166).2

cFam-trastuzumab deruxtecan-nxki may be considered in a later line if not used in second line.2

BICR, blinded independent central review; BRCA1/2, BReast CAncer gene 1 or 2; CBR, clinical benefit rate; CDK4/6, cyclin-dependent kinases 4 and 6; CI, confidence interval; CR, complete response; DCR, disease control rate; DOR, duration of response; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; HR–, hormone receptor-negative; HR+, hormone receptor-positive; IHC, immunohistochemistry; ISH, in situ hybridization; mBC, metastatic breast cancer; mDOR, median duration of response; mOS, median overall survival; mPFS, median progression-free survival; NCCN, National Comprehensive Cancer Network® (NCCN®); ORR, objective response rate; PFS, progression-free survival; PR, partial response; SD, stable disease.