ExteNET was a pivotal phase 3, global, multicenter, randomized, double-blind, placebo-controlled study1

Study population:

2840 women with early-stage HER2+ breast cancer; locally confirmed HER2 status; all patients had prior trastuzumab-based therapy within 2 years*


Primary endpoint:

invasive disease-free survival (iDFS)


Secondary endpoints:

overall survival, DFS-DCIS, distant DFS, time to distant recurrence, CNS metastases, safety


Stratification:

nodes 0, 1-3 vs 4+; ER/PR status; concurrent vs sequential trastuzumab-based therapy



CNS: central nervous system; DCIS: ductal carcinoma in situ; DFS: disease-free survival; ER: estrogen receptor; HER2: human epidermal growth factor receptor 2; PR: progesterone receptor

Select exclusion criteria: clinically significant cardiac, GI, or psychiatric comorbidities; inability to swallow pills.

Invasive disease-free survival (iDFS), defined as the time between the date of randomization to the first occurrence of invasive recurrence (local/regional, ipsilateral, or contralateral breast cancer), distant recurrence, or death from any cause, with 2 years and 28 days of follow-up.

The iDFS results of ExteNET are supported by an exploratory analysis of 5-year follow-up with 74.5% (2117/2840) of patients reconsented.

Patient characteristics were well balanced in the ExteNET trial

ER: estrogen receptor; PR: progesterone receptor

Percentage is based on the number of hormone receptor-positive patients. Tumors were assessed as being ER or PR positive on the basis of local pathology laboratory cutoffs. There was no protocol specification as to whether a 1% or 10% threshold should be used.

The number of patients who received neoadjuvant chemotherapy was 342 (24%) in the neratinib group and 379 (27%) in the placebo group.

IMPORTANT SAFETY INFORMATION

NERLYNX® (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.

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

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

For Full Prescribing Information, please click here.