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.
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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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