Abstract 116P
Background
Neratinib is registered in Europe as extended adjuvant treatment for patients (pts) with human epidermal growth factor receptor 2 positive (HER2+), hormone receptor positive (HR+) early breast cancer (eBC), who completed adjuvant trastuzumab (T)-based therapy <1 year ago. The phase III ExteNET study demonstrated clinically meaningful benefit for neratinib vs. placebo in this population, including significantly improved 5-year invasive disease-free survival (Δ5.1%, HR 0.58, 95% CI 0.41-0.82). ELEANOR is the first non-interventional study (NIS) to collect real-world data on neratinib use and treatment management in Germany, Austria, and Switzerland (NCT04388384).
Methods
Enrollment of 300 female pts with HER2+/HR+ eBC is planned in accordance with the EMA/Swissmedic product specifications. Primary endpoint is the proportion of pts adherent to neratinib treatment (i.e. neratinib use for ≥75% of treatment days). Secondary objectives include patient and disease characteristics, prior T-based treatments, effectiveness, safety, and patient-reported outcomes. Interim results based on 300 enrolled pts (enrollment set) observed for ≥3 months are reported.
Results
At data cut-off (5th Aug 2023), 286 pts with a median age of 52.0 years met the eligibility criteria and had at least one documented dose of neratinib (main analysis set), 73.4% of which were at increased risk of disease recurrence (defined as AJCC stage II-III or N1/N2/N3 or non-pCR). Most pts received prior neoadjuvant treatment (80.8%). Post-neoadjuvant anti-HER2 treatment included T monotherapy (27.6%), dual HER2 blockade with T plus pertuzumab (25.2%) and T-emtansine (T-DM1, 22.4%). At least one post-baseline safety assessment was documented for 288 pts treated with neratinib (safety analysis set). The most common adverse events of any grade in >10% pts were diarrhoea, nausea and fatigue with 81.3%, 22.2%, 19.8% respectively.
Conclusions
This preplanned interim analysis provides additional data for neratinib use in routine clinical practice without any new safety signals. Funding by Pierre Fabre Pharma.
Clinical trial identification
NCT04388384; study started at 2nd July 2020.
Editorial acknowledgement
Editing/Medical Writing support provided by Lydia Budiner.
Legal entity responsible for the study
Pierre Fabre Pharma.
Funding
Pierre Fabre Pharma.
Disclosure
R. Bartsch: Financial Interests, Personal, Invited Speaker: AstraZeneca, Seagen, Roche, Novartis, Eli Lilly, Pierre-Fabre, Daiichi, Gilead, MSD, Pfizer, Eisai, Gruenenthal; Financial Interests, Personal, Advisory Board: Daiichi, AstraZeneca, Roche, Novartis, Eli Lilly, Pierre-Fabre, MSD, Gilead, Seagen, Eisai, Gruenenthal, Menarini; Financial Interests, Institutional, Funding, Investigator Initiated Trial: Daiichi; Financial Interests, Institutional, Invited Speaker, Drug support for investigator initiated trial: MSD. N. Harbeck: Financial Interests, Personal, Invited Speaker: AstraZeneca, Daiichi Sankyo, Lilly, MSD, Novartis, Pierre Fabre, Roche, Seagen, Art Tempi, Onkowissen, Medscape, Gilead, Sanofi, Zuelligpharma, Viatris; Financial Interests, Personal, Other, IDMC: Roche; Financial Interests, Personal, Advisory Board: Sandoz-Hexal, Seagen, Aptitude Health, Pfizer, Gilead, Sanofi; Financial Interests, Personal, Other, Husband: WSG (Husband); Financial Interests, Personal, Ownership Interest: West German Study Group; Financial Interests, Institutional, Funding: AstraZeneca, BMS, Daiichi Sankyo, Lilly, MSD, Novartis, Pierre Fabre, Roche, Palleos, Seagen, TRIO, WSG; Non-Financial Interests, Member, Member German AGO Breast Guideline Committee: AGO Breast Committee; Non-Financial Interests, Member, Breast Cancer Educational Programs: ESO/ESCO; Other, Founding Editor: BreastCare Journal. D. Wrobel: Financial Interests, Personal, Advisory Board: Novartis, Roche; Financial Interests, Personal, Invited Speaker: Novartis, Roche; Financial Interests, Personal, Other, Honoraria: TEVA, AstraZeneca, Pfizer, Pierre Fabre GmbH. D. Guth: Financial Interests, Personal, Invited Speaker: Amgen, AstraZeneca, Aristo, Celgene, Gilead, Janssen, Lilly, Novartis, PharmaMar, Pfizer, Ribosepharm, Roche; Financial Interests, Personal, Advisory Role: Amgen, AstraZeneca, Aristo, Celgene, Gilead, Janssen, Lilly, Novartis, PharmaMar, Pfizer, Ribosepharm, Roche. M. Zaiss: Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, BeiGene, Daiichi, Deciphera, Eisai, Stemline, Novartis, Roche, Janssen, Pfizer, Lilly; Financial Interests, Personal, Other, Honoraria: AstraZeneca, RG, AKS, Vifor, Pfizer, Janssen, Novartis, AbbVie; Financial Interests, Personal and Institutional, Other, Honoraria: Roche, Eli Lilly; Financial Interests, Institutional, Other, Fees: GBG. J. Terhaag: Financial Interests, Personal and Institutional, Funding: Aurikamed; Financial Interests, Personal, Advisory Role, Honoraria: Seagen; Financial Interests, Personal, Other, registration fees: Lilly. K.R. Apel: Financial Interests, Institutional, Funding: Roche, Amgen, Lilly, ITF Pharma, GSK, Novartis, Gruenenthal; Financial Interests, Personal, Advisory Board: Roche, Amgen, Lilly, ITF Pharma, GSK, Novartis, Gruenenthal; Financial Interests, Personal, Invited Speaker, Honoraria: Roche; Financial Interests, Personal, Invited Speaker: Amgen, Lilly, ITF Pharma, GSK, Novartis, Gruenenthal. C. Vannier: Financial Interests, Personal, Full or part-time Employment: Pierre Fabre Pharma GmbH. D.I. Lüftner: Financial Interests, Personal, Advisory Board: AstraZeneca, Novartis, Pfizer, Daiichi Sankyo, Onkowissen, GSK; Financial Interests, Personal, Invited Speaker: Eli Lilly, Novartis, High5md, Loreal; Financial Interests, Institutional, Funding: Novartis. U. Breitenstein: Financial Interests, Personal, Advisory Board: Novartis, Roche, AstraZeneca, Eli Lilly, Pierre Fabre Pharma, Pfizer, SAKK, Stemline Genetics; Financial Interests, Personal, Other, Honoraria: Novartis, Roche, AstraZeneca, Eli Lilly, Pierre Fabre Pharma, Pfizer, SAKK. All other authors have declared no conflicts of interest.