
Efficacy
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ExteNET is a large phase III trial designed to investigate the efficacy of neratinib as an extended adjuvant treatment post trastuzumab-based therapy in HER2+ early breast cancer
ExteNET study is a randomised phase III trial evaluating the addition of 1 year of NERLYNX after trastuzumab in HER2+ early breast cancer.1-4 Patients were treated with chemotherapy and trastuzumab. At the time of the ExteNET trial patient recruitment, trastuzumab emtansine (TDM-1) was not licensed or available for adjuvant treatment in early breast cancer therefore patients included in the ExteNET trial only received prior trastuzumab.1
Primary endpoint
invasive disease-free survival (iDFS) at 2 years after randomisation*
Secondary endpoints
DFS-DCIS, time to distant recurrence, distant DFS, cumulative incidence of first occurrence of CNS recurrences, overall survival, safety
Other analyses
biomarkers, health outcome assessment (FACT-B, EQ-5D)
Stratification by
nodal status, HR status, concurrent vs sequential trastuzumab adjuvant regimen
NERLYNX significantly improves invasive disease-free survival (iDFS) vs placebo in the ITT population2,3,5
ExteNET study met its primary endpoint and demonstrated the benefit of adding NERLYNX after a trastuzumab-based therapy for HER2+ early breast cancer patients.5
Primary endpoint presented in the Summary of Product Characteristics (SmPC) is the 2-year data in ITT population, iDFS after adjuvant therapy at 2 years: 94.2% vs 91.9% NERLYNX vs placebo; absolute benefit 2.3%.
33% reduction of the relative risk of disease recurrence vs placebo in the ITT population*5
NERLYNX shows superior benefit in HER2+/HR+ early breast cancer patients who have completed trastuzumab-based therapy less than 1 year ago, granting marketing autorisation in this specific population*†‡1,5
Invasive disease-free survival (iDFS) in HER2+/HR+ <1 year from completion of prior trastuzumab-based therapy population:
Some patients are at a heightened risk of recurrence*1,6-8
Risk considerations in early-stage HER2+ breast cancer patients
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One or more positive nodes6
-
Tumor diameter ≥ 2cm8
-
Residual disease after neoadjuvant1,7,8
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High Ki-67
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High BMI
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Medium/High grading
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Younger age
Anna, pre-menopausal patient
with node-positive disease
Anna is disease-free, following surgery, adjuvant trastuzumab-based therapy and hormone therapy.
Sofia, post-menopausal patient
with no pCR following neoadjuvant treatment
Sofia has undergone a number of cycles of neoadjuvant therapy, surgery and adjuvant therapy, and is currently disease-free
NERLYNX can help reduce Anna’s risk of recurrence*1,4,6
Anna Node-positive patient
For HER2+ node-positive patients, like Anna, the risk of recurrence increases with the number of lymph nodes involved:*
- 1-3 nodes involved: 25% relapse
- ≥4 nodes involved: 44% relapse
at 10 years following 1 year trastuzumab*†6
See ExteNET study results in the node positive subgroup of patients
NERLYNX can help reduce Sofia’s risk of recurrence*1,4,7
Sofia No pCR patient after neoadjuvant treatment
For patients like Sofia, who did NOT achieve a pCR and received trastuzumab-DM1, the risk of recurrence is:
-
11,7% at 3 years following 42 weeks of T-DM1*†7
In exploratory subset analysis of patients who did not achieve a pCR after trastuzumab-based therapy, NERLYNX demonstrates an absolute benefit vs placebo:‡1,4