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Study Design Study Results Safety Dosing NCCN Guidelines®

Metastatic Study Design
Metastatic Study Design

NALA was a pivotal phase 3, global, multicenter, randomized, open-label study of NERLYNX + capecitabine vs lapatinib + capecitabine3,22

  • Study population: 621 adults with HER2+ mBC (HER2 status was confirmed centrally); all patients had ≥2 prior lines of HER2-directed therapy for mBC; asymptomatic or stable brain metastases permitted
  • Co-primary endpoints: PFS (confirmed centrally) and OS
  • Secondary endpoints: PFS (confirmed locally), ORR, DoR, time to intervention for symptomatic CNS metastases, safety, health outcomes
  • Stratification: Number of prior HER2 therapies for mBC; hormone receptor status; disease location; geographic location

PATIENTS IN NALA WERE HEAVILY PRETREATED

  • All patients received prior trastuzumab. In addition, 51.8% of patients received prior trastuzumab emtansine, 40.4% of patients received prior pertuzumab, and 32.9% of patients received trastuzumab emtansine, pertuzumab, and trastuzumab for mBC prior to NERLYNX22

CNS: central nervous system; DoR: duration of response; HER: human epidermal growth factor receptor; mBC: metastatic breast cancer; ORR: objective response rate; OS: overall survival; PFS: progression-free survival.

*Loperamide was administered for the first 21 days of treatment with NERLYNX + capecitabine: 4 mg with the first dose of NERLYNX, followed by 2 mg every 4 hours for the first 3 days, followed by 2 mg every 6 to 8 hours through day 21.2

See NALA 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:

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  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 (neratinib) tablets Prescribing Information, Puma Biotechnology, Inc. 04/20.
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