NICE has approved neratinib (Nerlynx) for extended adjuvant treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)‑positive early stage breast cancer in adults who completed adjuvant trastuzumab-based therapy less than one year ago. Neratinib is recommended if trastuzumab is the only HER2‑directed adjuvant treatment the patient has received and if there is residual invasive disease in the breast or axilla after neoadjuvant chemotherapy-based treatment.
The key evidence to support the decision comes from the phase 3 randomised controlled ExteNET trial (n=2840) that compared neratinib treatment with placebo in women with HER2-positive breast cancer who had completed adjuvant trastuzumab treatment within two years. The company based its submission on a subgroup of women with early hormone receptor-positive cancer who were less than 1 year from completing adjuvant trastuzumab-based treatment (label population; n=1334). Neratinib showed better clinical effectiveness and fewer side effects in this group than in the whole trial.
The five-year hazard ratio (HR) for invasive disease-free survival (DFS) for the whole trial was 0.73 (95% CI 0.57-0.92). The five-year HR for invasive DFS for the label population was 0.58 (95% CI 0.41-0.82), suggesting a statistically significant improvement in invasive DFS with neratinib compared with placebo.
Overall survival data had not been fully analysed at the time of the appraisal.