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Study Design Study Results Safety Dosing NCCN Guidelines®

EARLY-STAGE STUDY DESIGN
Early-Stage Study Design

ExteNET was a pivotal phase 3, global, multicenter, randomized, double-blind, placebo-controlled study2,3

NERLYNX is the first and only HER2-directed small molecule approved in HER2+ early breast cancer2,3,20

Event-based OS analysis was reached at 8 years1,‡

  • Study population: 2840 women with early-stage HER2+ breast cancer and locally confirmed HER2 status; all patients had prior trastuzumab-based therapy§
  • 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 or 4+), ER/PR status, concurrent vs sequential trastuzumab-based therapy

*Invasive disease-free survival 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.3

†Results of ExteNET are supported by descriptive analyses after 5 years of follow-up, with 74.5% (2117/2840) of patients reconsented.2

‡A definitive analysis of OS was planned when 248 deaths had occurred in the ITT population; median follow-up of 8.0 years.1

§Select exclusion criteria: clinically significant cardiac, GI, or psychiatric comorbidities; inability to swallow pills.2

CNS: central nervous system; DFS-DCIS: disease-free survival including ductal carcinoma in situ; DFS: disease-free survival; ER: estrogen receptor; HER: human epidermal growth factor receptor; ITT: intent-to-treat; OS: overall survival; PR: progesterone receptor.

Patient characteristics were balanced in the ExteNET trial2

21

*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.

ER: estrogen receptor; PR: progesterone receptor.

See ExteNET efficacy data

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:

For Full Prescribing Information, please click here.

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Reference:

  1. Chan A, Moy B, Mansi J, et al. Final efficacy results of neratinib in HER2-positive hormone receptor-positive early-stage breast cancer from the phase III ExteNET trial. Clin Br Cancer. 2020; In press.
  2. Martin M, Holmes FA, Ejlertsen B, et al. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(12):1688-1700.
  3. NERLYNX [package insert]. Los Angeles, CA: Puma Biotechnology, Inc.
  4. Cameron D, Piccart-Gebhart MJ, Gelber RD, et al. 11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet. 2017;389(10075):1195-1205.
  5. Perez EA, Romond EH, Suman VJ, et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32(33):3744-3752.
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  21. Puma Biotechnology, Inc. Data on file
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  23. Puma Biotechnology. FDA ODAC Sponsor Presentation. May 24, 2017.
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