Timo Schinköthe (Kirchheim, Germany)
Service GmbHAuthor Of 1 Presentation
75P - Interim analysis (n=150) of the multi-national, prospective, non-interventional ELEANOR study observing real-life extended adjuvant treatment with neratinib in patients with HER2+ / HR+ early breast cancer (eBC) (ID 90)
- Nadia Harbeck (Munich, Germany)
- Denise Wrobel (Bamberg, Germany)
- Matthias Zaiss (Freiburg im Breisgau, Germany)
- Dagmar Guth (Plauen, Germany)
- Andrea Distelrath (Plauen, Germany)
- Jürgen Terhaag (Eggenfelden, Germany)
- Andreas Lorenz (Hildburghausen, Germany)
- Rupert Bartsch (Vienna, Austria)
- Urs Breitenstein (Zurich, Switzerland)
- Michael Schwitter (Chur, Switzerland)
- Marija Balic (Graz, Austria)
- Christian Jackisch (Offenbach am Main, Germany)
- Volkmar Müller (Hamburg, Germany)
- Gabriel Rinnerthaler (Salzburg, Austria)
- Marcus Schmidt (Mainz, Germany)
- Khalil Zaman (Lausanne, Switzerland)
- Timo Schinköthe (Kirchheim, Germany)
- Diana Luftner (Berlin, Germany)
Abstract
Background
Neratinib is registered in Europe as extended adjuvant treatment for adult patients with Human Epidermal Growth Factor Receptor 2-positive (HER2+) and Hormone receptor-positive (HR+) eBC within one year after completed adjuvant trastuzumab-based therapy (“EMA-/Swiss-label” population). In the ExteNET trial, extended adjuvant neratinib improved the absolute 5-year invasive disease-free survival rate by 5.1% vs. placebo in this population (90.8% vs. 85.7%; HR 0.58 [95% CI 0.41-0.82]). More pronounced benefit was observed in patients with non-pCR after neoadjuvant trastuzumab-based therapy and/or in patients who completed one year of neratinib (descriptive post-hoc analyses). In the absence of primary prophylaxis, grade 3 diarrhea occurred in 39% of patients in the ExteNET trial. ELEANOR is the first study to investigate real-world use of neratinib and its management in eBC patients in Germany, Austria and Switzerland.
Methods
300 patients with HER2+/HR+ eBC will be enrolled in accordance with the specifications of the local Summary of Product Characteristics. Primary objective is the proportion of patients adherent to neratinib treatment (i.e., neratinib intake for ≥75% of treatment days). Secondary objectives include analysis of prior trastuzumab-based therapies (including pertuzumab and T-DM1), neratinib dosing and management, relapses, safety / tolerability, and health-related quality of life (using the CANKADO eHealth application).
Results
Between July 2020 and Feb 2022, 206 patients were enrolled at 59 sites; patient enrollment is ongoing. We will present results from the interim analysis on the first 150 enrolled patients who have been observed for at least 3 months (data cut Nov 2021, analyses ongoing). Baseline demographics and tumor characteristics, prior trastuzumab-based treatments, and neratinib safety and tolerability will be reported.
Conclusions
ELEANOR will help to characterize adherence to neratinib and use of extended adjuvant HER2-targeted therapy in the current treatment landscape focusing on neratinib management after different prior therapies.
Editorial acknowledgement
Editorial assistance was provided by Anna Resch, Pierre Fabre Pharma GmbH, Freiburg, Germany.
Legal entity responsible for the study
Pierre Fabre Pharma GmbH (Freiburg, Germany), Pierre Fabre Pharma Austria (Wels, Austria) and Pierre Fabre Pharma AG (Allschwil, Switzerland).
Funding
Pierre Fabre Pharma GmbH (Freiburg, Germany), Pierre Fabre Pharma Austria (Wels, Austria) and Pierre Fabre Pharma AG (Allschwil, Switzerland).
Disclosure
N. Harbeck: Financial Interests, Personal, Other: Amgen, AstraZeneca, Daiichi Sankyo, Exact Sciences, Eli Lilly, Gilead, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Sandoz, Seagen, WSG; Financial Interests, Institutional, Other: clinical trials. D. Wrobel: Financial Interests, Personal, Other: Roche, Novartis. M. Zaiss: Financial Interests, Personal, Other: Celgene, AstraZeneca, RG, AKS, Vifor, Pfizer, Janssen, Novartis, AbbVie; Financial Interests, Personal and Institutional, Other: Roche, Eli Lilly; Financial Interests, Institutional, Other: GBG. R. Bartsch: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: Daiichi; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: Seagen; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Institutional, Funding, Investigator Initiated Trial: Daiichi; Financial Interests, Institutional, Invited Speaker, Drug support for investigator initiated trial: MSD. U. Breitenstein: Financial Interests, Institutional, Other: Novartis, Roche, AstraZeneca, Eli Lilly, Pierre Fabre, Pfizer, SAKK; Non-Financial Interests, Personal, Other: SGMO, SGS, SAKK. M. Schwitter: Financial Interests, Personal and Institutional, Other: Pierre Fabre. M. Balic: Financial Interests, Personal, Other: Amgen, Pierre Fabre, Daiichi Sankyo, Bayer, Samsung, Seagen; Financial Interests, Personal and Institutional, Other: Novartis, Eli Lilly, Pfizer, Celgene, AstraZeneca, MSD, Roche; Financial Interests, Institutional, Other: ABCSG, IBCSG, BIG. C. Jackisch: Financial Interests, Personal, Other: Roche, AstraZeneca, Eisai, Pfizer, Eli Lilly, Novartis, Exact Sciences; Non-Financial Interests, Personal, Other: Roche. V. Müller: Financial Interests, Personal, Other: Amgen, AstraZeneca, Daiichi Sankyo, Eisai, GSK, Pfizer, MSD, Medac, Novartis, Roche, Teva, Seagen, Onkowissen, high5 Oncology, Medscape, Gilead; Financial Interests, Institutional, Other: Novartis, Roche, Seattle Genetics, Genentech. G. Rinnerthaler: Financial Interests, Personal and Institutional, Other: Roche, Pierre Fabre; Financial Interests, Personal, Other: AstraZeneca, Novartis, BMS, Roche, Pfizer, Eli Lilly, MSD, Daiichi Sankyo. M. Schmidt: Financial Interests, Personal, Other: Amgen, Seagen; Financial Interests, Personal and Institutional, Other: Pierre Fabre, Roche, Pfizer, Novartis, AstraZeneca, Eisai, Pantarhei, BioNTech; Financial Interests, Institutional, Other: Genentech; Non-Financial Interests, Personal, Other: Roche, Pfizer, Pantarhei, BioNTech; Non-Financial Interests, Personal, Other, Issued patent EP: 2951317, Issued patent EP: 2390370: Other. K. Zaman: Financial Interests, Personal and Institutional, Other: Roche; Financial Interests, Institutional, Other: Eli Lilly, Novartis, MSD Oncology, Mylan, Daiichi Sankyo, Pierre Fabre, Genentech. T. Schinköthe: Financial Interests, Personal, Full or part-time Employment: CANKADO Service GmbH; Financial Interests, Personal, Ownership Interest: CANKADO Service GmbH. D. Lüftner: Financial Interests, Institutional, Other: Novartis; Financial Interests, Personal, Other: Amgen, Pfizer, GSK, Loreal, Teva, Gilead, Sanofi Aventis, Daiichi Sankyo, Samsung, AstraZeneca, Novartis. All other authors have declared no conflicts of interest.