OBJECTIVES: Neratinib is an oral pan-HER tyrosine kinase inhibitors approved in the EU for the extended adjuvant treatment of adults with HR+/HER2+ EBC who completed adjuvant trastuzumab-based therapy less than 1 year prior to inclusion. Since 2017, an EAP granted neratinib access to patients with HER2+ EBC in Europe. The NEAR study was designed to describe neratinib use in patients treated in the context of this EAP.

METHODS: The retrospective, multi-country NEAR study included adult patients who had received at least one dose of extended adjuvant neratinib for HER2+ EBC between 1^st August 2017 and 31^st December 2020, in the context of the EAP and were followed-up until 5^th July 2022. Data on patient and tumor characteristics, as well as previous cancer treatments, were collected. Neratinib treatment patterns, reason for discontinuation, adverse events (AEs), clinical outcomes, and OS were collected during the study period. Final results will be presented using advanced visualization techniques.

RESULTS: In total, 108 eligible patients were included with a median follow-up of 28.4 months. Sequences of anti-HER2 therapy will be visualized thanks to an algorithm-clustering method (TAK®). The median duration of neratinib use was 12.3 months. Among the identified profiles, 68.5% of patients met the EU label indication (HR+, completed adjuvant trastuzumab-based therapy ≤1 year before neratinib initiation). Prior anti-HER2 therapies will be explored using a heatmap, trastuzumab use was the most represented (87.8%). More than two thirds of patients completed their treatment period as planned. Two thirds of patients reported at least one AE (any grade); of these 10.2% were grade 3 and 1.9 % were grade 4.

CONCLUSIONS: This study provided real-life data on extended adjuvant neratinib use in HER2+ EBC in the context of the European EAP. Results of this study were consistent with previous data. Advanced visualizations methods support the communication of results.