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Just 1 risk factor further increases risk of recurrence4-10

RISK CONSIDERATIONS IN HER2+ EARLY BREAST CANCER PATIENTS

1 or more positive nodes

  • At 10 years, 25% of patients with 1–3 positive nodes experienced recurrence4
  • At 10 years, 45% of patients with ≥4 positive nodes experienced recurrence4

Tumor diameter ≥2 cm

  • Tumors 2 cm to 5 cm in diameter were associated with a 53% increase in the risk of recurrence5,*
  • Tumors >5 cm in diameter were associated with an 81% increase in the risk of recurrence5,*

Overall risk of recurrence increases over time

  •  The risk of recurrence increased ~3% annually on average in HER2+ patients after receiving trastuzumab-based therapy4,5
  •  Recurrence may occur later in HR+ patients, putting younger women with HER2+, HR+ disease at increasing long-term risk6

Other risk factors include:

  •  Age at diagnosis7
  •  Smoking9
  •  High BMI8
  •  Lack of pCR10

BMI: body mass index; HER: human epidermal growth factor receptor; HR+: hormone receptor-positive; pCR: pathologic complete response.

*Compared with tumors less than 2 cm in diameter.

Recurrence refers to disease-free survival over 10 years, defined as the time from enrollment to documentation of the first of any of these events: local, regional, or distant recurrence of breast cancer; a contralateral breast cancer; a second primary cancer; or death as a result of any cause.

Monoclonal antibodies have improved but not eliminated the risk of recurrence4,5,11-13

RECURRENCE RATES IN HER2+ EARLY BREAST CANCER CLINICAL TRIALS

Once distant recurrence has occurred, the disease remains largely incurable and patient survival is low14,15

AC: anthracycline plus cyclophosphamide; HER: human epidermal growth factor receptor; ITT: intent to treat; pCR: pathologic complete response; T: taxane; TC: taxane plus carboplatin.

*Recurrence refers to disease-free survival, defined as the time from randomization to the first occurrence of any of these events: recurrence of breast cancer at any site; the development of ipsilateral or contralateral breast cancer, including ductal carcinoma in situ but not lobular carcinoma in situ; second nonbreast malignant disease other than basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix; or death from any cause.4

Recurrence refers to disease-free survival, defined as the time from enrollment to documentation of the first of any of these events: local, regional, or distant recurrence of breast cancer; a contralateral breast cancer; a second primary cancer; or death as a result of any cause.5

Recurrence refers to disease-free survival, defined as the time from randomization to breast cancer recurrence, a second primary cancer (excluding contralateral ductal carcinoma in situ), or death from any cause.12

§Recurrence refers to invasive disease–free survival, defined as time from randomization to the first occurrence of any of the following events: recurrence of ipsilateral invasive breast tumor, recurrence of ipsilateral locoregional invasive breast cancer, contralateral invasive breast cancer, a distant disease recurrence, or death from any cause.13

Preventing CNS metastases remains a critical unmet need in HER2+ breast cancer16,17

katherine trial

(trastuzumab emtansine)

56%

of patients who experienced DISTANT recurrence had CNS metastases as the first site of recurrence (44/78)

APHINITY TRIAL

(pertuzumab)

35%

OF PATIENTS WHO EXPERIENCED DISTANT RECURRENCE HAD CNS METASTASES AS THE FIRST SITE OF RECURRENCE (49/141)

Trastuzumab emtansine did not reduce the incidence of CNS metastases16
  • 6.1% of patients had CNS recurrence with trastuzumab emtansine vs 5.4% with trastuzumab
In patients with CNS recurrence, median OS was numerically lower in the trastuzumab emtansine arm vs trastuzumab16
  • Median OS of 12.5 months with trastuzumab emtansine vs 14.3 months with trastuzumab
Overall, up to 50% of patients with advanced HER2+ breast cancer will develop brain metastases18-20
CNS: central nervous system; HER: human epidermal growth factor receptor; OS: overall survival.

IMPORTANT SAFETY INFORMATION

NERLYNX® (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS: The most common adverse reactions (reported in ≥5% of patients) were:

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

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