Nerlynx (neratinib) demonstrates a 5.1% invasive disease-free survival benefit versus placebo in the phase III ExteNET trial evaluating Nerlynx in HER2-positive, hormone receptor-positive early stage breast cancer.
Nerlynx is sponsored by Pierre Fabre. Results from the trial were published in Clinical Breast Cancer.
In the HR+ /< 1 yr patient population, the absolute 5-year invasive disease-free survival benefit versus placebo was 5.1% and absolute 8-year overall survival benefit was 2.1%. The 5-year cumulative incidence of Central Nervous System metastases was 0.7% in the neratinib arm and 2.1% in the placebo arm.
In the HR+/ <1 yr, subgroup of patients who did not achieve pCR upon neo-adjuvant treatment, and hence were at a high risk of disease recurrence, the absolute 5-year iDFS benefit in the neratinib arm versus placebo was 7.4% (HR=0.60; 95% CI 0.33???1.07) and the 8- year overall survival benefit was 9.1% (HR=0.47; 95% CI 0.23- 0.92).
The primary endpoint of the trial was invasive disease-free survival, with overall survival as a key secondary endpoint. Within the European Union, Nerlynx is approved in adult patients with HER2+/HR+ early breast cancer who initiated treatment within one year of completing an adjuvant trastuzumab based regimen.
ExteNET is a multicenter, randomized, double-blind, phase III trial of 2,840 HER2-positive eBC patients who received neratinib after neoadjuvant and/or adjuvant therapy with chemotherapy and trastuzumab.
Patients were stratified by hormone receptor, lymph node status and sequential vs concomitant chemotherapy administration, and randomly assigned to one year of treatment with either oral neratinib 240 mg/day or placebo.
