NICE has published draft guidance recommending neratinib as an option for the extended adjuvant treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive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 only if:
- Trastuzumab is the only HER2-directed treatment in the adjuvant setting they have had, and
- If they had neoadjuvant treatment, they still had residual invasive disease in the breast or axilla following the neoadjuvant treatment.
Evidence to support the draft recommendations was drawn from the phase 3 randomised controlled ExteNET trial (n=2840) which 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 had completed adjuvant trastuzumab-based treatment less than one year ago (n=1334). Neratinib showed better clinical effectiveness and fewer side effects than the whole trial.
In ExteNET, 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 for neratinib compared with placebo. Overall survival data had not been fully analysed at the time of appraisal.
NICE estimates that around 1600 people would be eligible for treatment with neratinib following adjuvant treatment with trastuzumab.
The draft guidance is now open for public consultation. Consultees, including the company, healthcare professionals, and members of the public are able to comment on the draft recommendations via the NICE website until 28 August. All comments received during the consultation period will be considered by the committee at its meeting in September.