Dr. Isaacs Discusses the Role of Neratinib in HER2+ Breast Cancer

Claudine Isaacs, MD
Published: Thursday, Jan 25, 2018



Claudine Isaacs, MD, professor, medical director, Fisher Center for Familial Cancer Research, co-director, Breast Cancer Program, Georgetown University/Lombardi Cancer Center, discusses the role of neratinib (Nerlynx) in the treatment landscape of HER2-positive breast cancer.

In July 2017, the FDA approved neratinib for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab (Herceptin). The approval followed a 12-4 recommendation from the FDA’s Oncologic Drugs Advisory Committee, which was based on data from the phase III ExteNET trial and the phase II CONTROL trial.

The invasive disease-free survival rate in ExteNET at 2 years was 94.2% with neratinib versus 91.9% with placebo. The results indicated that the benefit may vary based on hormone receptor status. An exploratory subgroup analysis indicated that neratinib lowered the risk of recurrence by 51% (HR, 0.49; 95% CI, 0.31-0.75) in HR-positive patients, compared with 7% in HR-negative patients (HR, 0.93; 95% CI, 0.60-1.43).

Although the data with neratinib was impressive, Isaacs says that clinicians are not sure how to position the agent in the treatment regimen.


Claudine Isaacs, MD, professor, medical director, Fisher Center for Familial Cancer Research, co-director, Breast Cancer Program, Georgetown University/Lombardi Cancer Center, discusses the role of neratinib (Nerlynx) in the treatment landscape of HER2-positive breast cancer.

In July 2017, the FDA approved neratinib for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab (Herceptin). The approval followed a 12-4 recommendation from the FDA’s Oncologic Drugs Advisory Committee, which was based on data from the phase III ExteNET trial and the phase II CONTROL trial.

The invasive disease-free survival rate in ExteNET at 2 years was 94.2% with neratinib versus 91.9% with placebo. The results indicated that the benefit may vary based on hormone receptor status. An exploratory subgroup analysis indicated that neratinib lowered the risk of recurrence by 51% (HR, 0.49; 95% CI, 0.31-0.75) in HR-positive patients, compared with 7% in HR-negative patients (HR, 0.93; 95% CI, 0.60-1.43).

Although the data with neratinib was impressive, Isaacs says that clinicians are not sure how to position the agent in the treatment regimen.



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