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In this activity, we will explore the role of abemaciclib, an oral CDK4/6 inhibitor that offers sustained clinical benefit for patients with HR+, HER2- node-positive, high-risk early breast cancer and metastatic breast cancer. In high-risk, early-stage breast cancer, the monarchE trial demonstrated that adding abemaciclib to adjuvant endocrine therapy improved overall survival and reduced the risk of invasive disease recurrence compared with endocrine therapy alone.1-3 In the metastatic setting, MONARCH 3 showed that first-line treatment with abemaciclib plus a nonsteroidal aromatase inhibitor lowered the risk of disease progression and produced clinically meaningful, not statistically significant overall survival gains.2 For patients whose disease progressed on prior endocrine therapy, MONARCH 2 demonstrated a statistically significant overall survival advantage with abemaciclib combined with fulvestrant.3 Across these pivotal studies, abemaciclib consistently showed a manageable safety profile, with adverse events generally low grade and managed through proactive supportive care and dose adjustments without compromising efficacy.4
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Johnston S, Martin M, O’Shaughnessy J, et al. Overall survival with abemaciclib in early breast cancer. Ann Oncol. 2026;37(2):155–165.
Goetz MP, Toi M, Huober J, et al. Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: final overall survival results of MONARCH 3. Ann Oncol. 2024;35:718–27.
Sledge GW, Jr., Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy-MONARCH 2: a randomized clinical trial. JAMA Oncol. 2020;6:116–24.
Rugo HS, O’Shaughnessy J, Boyle F, et al. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022;33:616–27.
Stephen Johnston is Head of Medical Oncology, Head of the Breast Unit and Professor of Breast Cancer Medicine at The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London. He also serves as Clinical Director of the Breast, Lung and AOS Clinical Business Unit at The Royal Marsden. His clinical and research focus is metastatic breast cancer, particularly mechanisms of endocrine resistance, and he is chief investigator of multiple phase II/III trials of novel endocrine and targeted therapies. He has authored over 250 peer-reviewed publications, is a frequent international speaker, and holds key roles on scientific committees and editorial boards, including as Deputy/Associate Editor of Breast Cancer Research and Clinical Breast Cancer.
Advisory fees from Eli Lilly, Novartis, Pfizer, Puma Biotechnology, Novartis, and Sanofi Genzyme. Honoraria from AstraZeneca, Eli Lilly, Novartis Eisai, Pfizer, Roche-Genentech, and Sanofi Genzyme. Research funding from AstraZeneca, Eli Lilly, Novartis, Pfizer, Puma Biotechnology, and Roche-Genentech.
Patrick Neven is a professor of gynaecological oncology at University Hospitals Leuven and a member of the Multidisciplinary Breast Centre. His research focuses on endocrine therapy in breast cancer, and he has served as principal investigator on numerous clinical trials. He has published extensively, is a frequent national and international speaker, and holds leadership roles in scientific societies, including President of the Belgian Society of Senology.
Honoraria from AstraZeneca, Eli Lilly, Gilead, Menarini, Novartis, Pfizer, and Roche. Travel support from AstraZeneca, Eli Lilly, Novartis, Pfizer, and Roche.
Valentina Guarneri is a professor of oncology at the University of Padua, Head of Oncology Division 2 at the Istituto Oncologico Veneto, and head of the Specialization School in Medical Oncology at the University of Padua. Her research focuses on clinical and translational breast cancer research, and she has authored more than 200 peer-reviewed publications.
Advisory fees from AstraZeneca, Daiichi Sankyo, Eli Lilly, Gilead, Menarini Stemline, MSD, Novartis, Olema Oncology, Pfizer, Pierre Fabre, and Roche. Speaker fees from AstraZeneca, Daiichi Sankyo, Eli Lilly, Exact Sciences, Gilead, GSK, Menarini Stemline, Novartis, Roche, and Zentiva. Expert testimony fees from Eli Lilly.
This activity has been funded by Eli Lilly and Company Ltd.
Eli Lilly and Company Ltd. provided financial support and video content, and has had input into the detailed project scope. This activity is provided by Touch Medical Communications (TMC) for touchONCOLOGY.
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This activity has been funded by Eli Lilly and Company Ltd.
Eli Lilly and Company Ltd. provided financial support and video content, and has had input into the detailed project scope. This activity is provided by Touch Medical Communications (TMC) for touchONCOLOGY.
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Eli Lilly and Company Ltd. provided financial support and video content, and has had input into the detailed project scope. This activity is provided by Touch Medical Communications (TMC) for touchONCOLOGY.
No endorsement by Eli Lilly or TMC of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in TMC activities. TMC accepts no responsibility for errors or omissions.
The views and opinions expressed are those of the faculty and do not necessarily reflect those of any sponsor.
° Ein statistisch signifikanter OS-Vorteil wurde in der ITT-Population beobachtet, hauptsächlich beeinflusst durch die zulassungsrelevante Kohorte 1 (91 % der ITT). Verzenios® ist für Kohorte 1 zugelassen; die OS-Analyse in dieser Subgruppe war jedoch weder auf Signifikanz gepowert noch alpha-kontrolliert. Nach der primären IDFS-Analyse wurde der OS-Analyseplan nach Rücksprache mit den Zulassungsbehörden geändert, um die Anzahl der finalen Ereignisse von 390 auf 650 zu erhöhen und so eine Nachbeobachtungszeit von ≥ 5 Jahren sicherzustellen.1,2
1. Johnston S, Martin M, O’Shaughnessy J, et al. Overall survival with abemaciclib in early breast cancer. Ann Oncol. 2026;37(2):155–165. doi:10.1016/j.annonc.2025.10.005
2. Rastogi P, O’Shaughnessy J, Martin M, et al. Adjuvant Abemaciclib Plus Endocrine Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, High-Risk Early Breast Cancer: Results From a Preplanned monarchE Overall Survival Interim Analysis, Including 5-Year Efficacy Outcomes. J Clin Oncol. 2024;42(9):987-993. doi:10.1200/JCO.23.01994
3. Fachinformation Verzenios® (aktueller Stand)
Verzenios® ist in Kombination mit einer ET angezeigt für die adjuvante Behandlung von erwachsenen Patient:innen mit Hormonrezeptor (HR)-positivem, humanem epidermalen Wachstumsfaktor-Rezeptor-2 (HER2)-negativem, nodal-positivem Brustkrebs im frühen Stadium mit einem hohen Rezidivrisiko#. Bei prä- oder perimenopausalen Frauen sollte die endokrine Aromatasehemmer-Therapie mit einem LHRH-Agonisten (LHRH = Luteinising Hormone Releasing Hormone) kombiniert werden.
* = Indication text for Verzenios in eBC
# = Hohes Rezidivrisiko definiert als ≥ 4 positive axilläre Lymphknoten oder 1–3 positive axilläre Lymphknoten und mind. eins der folgenden Kriterien: Tumorgröße ≥ 5 cm oder histologischer Grad 3.3
CMAT-13172. März/2026
Art. 42 Any support or sponsorship, whether full or partial, provided to healthcare professionals for participation in scientific events, national or international, must not be conditioned upon the prescription, dispensing, and/or promotion or advertising of any type of medication.
Material destinado exclusivamente a profissionais de saúde com habilitação para dispensar e prescrever medicamentos.
PP-AL-BR-1821. Março/2026
PP-AL-ES-1483. Marzo/2026
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