119P HER2+ early-stage breast cancer treated with extended adjuvant neratinib in the context of the European Early Access Program: NEAR study final results

• DOI: 10.1016/j.esmoop.2024.103107
• Publication Date: 2024-05-17T11:19:11Z
• Authors: T. Silovski; A. Cano Jimenez; M. Krizic; N. Dedic Plavetic; X. Gonzalez Farre; A.L. Guerrero Zotano; C.J. Cabasag; F. Beghdad; O. Dialla; M. Zivanov; O. Romano; G. Hoste; M. De Laurentiis
• Keywords: Neratinib

Neratinib is approved based on the phase III ExteNET study in Europe since 2018 to treat adult patients with Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2-positive (HR+/HER2+) early-stage breast cancer (eBC) completing adjuvant trastuzumab-based therapy <1 year ago (EU label). A 2017 Early Access Program (EAP) granted neratinib access awaiting product availability. The eBC treatment landscape has evolved ExteNET, and there a need assess safety effectiveness recent landscape. NEAR retrospective, observational Belgium, Croatia, France, Italy, Spain adults HER2+ receiving ≥1 dose of context EAP between Aug 1, 2017, Dec 31, 2020. Patient characteristics were presented 2023.1 Here we present data patterns, safety, 2-year effectiveness. As Jan 2023, 108 included full analysis set (FAS), which 92 HR+ 74 met EU label criteria; median follow up was 28 months. Key patient are summarised table. Initial 240 mg 87% both FAS subgroup; rest received <240 mg. most common adverse event (AE) diarrhoea (all grades/grades 3–4: 58%/8% FAS; 53%/8% subgroup), followed by other gastrointestinal AEs. Prophylactic antidiarrhoeal given 44% 47% subgroup. At 2 years, subgroups, invasive/distant disease-free survival 93%/94% 95%/96%, respectively; overall 98% 97%. No central nervous system metastases observed.Table: 119PKey characteristics1, pre-treatments received1, patternsFAS (N=108)EU subgroup (n=74)Median age [min, max], years48 [30, 72]49 72]Pre-menopausal, %3741Stage I, %Stage II + III, %Missing, %17749157411High recurrence risk profile‡, %8181Prior neoadjuvant therapy, %5865Prior anti-HER2 %Of trastuzumab, %91889190Median months max] from initiation4.6 [0.3, 24]3.2 12]Median neratinib12.3 [0.03, 16]12.1 16]‡Stage II/III or N+ no pathologic complete response Open table new tab ‡Stage This provides additional supporting use management extended clinical practice.