Abemaciclib's New Overall Survival Data in Early Breast Cancer: Findings from MonarchE trial - Video
Overview
In this short video, Prof Stephen Johnston, Consultant Medical Oncologist, Royal Marsden Hospital and Institute of Cancer Research, London, highlights Abemaciclib’s benefit in the adjuvant curative setting for patients with HR+, HER2-, node positive, early breast cancer at high risk of recurrence. This was confirmed in the recent 7-year follow-up data for the MonarchE trial presented at the 2025 ESMO Congress.1,2
Overall survival is the gold standard endpoint in oncology trials but it's very challenging to achieve, particularly in HR+ early breast cancer.3,4
Abemaciclib is currently the only CDK4/6 inhibitor to demonstrate a proven overall survival (OS) benefit in the curative setting and 2 years of treatment. 1,2,5,6,7
The data reveals a 16.5% reduction in the risk of death, representing a 2% absolute improvement at seven years in the cohort 1 subset of the trial population.1,2,5,6 Furthermore, breast cancer-specific deaths were reduced from 11% to 8.3%, and the number of patients living with metastatic disease decreased from 9.7% to 6.5%.1,2
He also emphasizes that the greatest risk of recurrence for these patients is within the first two years. It’s important to deal with any microscopic metastatic disease and prevent the recurrence and development of metastases.8,9,10
Nodal burden is the single most important risk factor, and those with four or more nodes have greater than 30% risk of recurrence at five years. But if the patients have one to three nodes, they need additional high-risk features such as grade three or large tumor size, and that then more than doubles their risk of recurrence if they have a low nodal burden.2,7,11,12
So, four or more nodes, or if one to three nodes, histological grade three or large tumor size are the features that can identify this risk of recurrence.7
The latest invasive disease free survival (IDFS) curves continue to show sustained benefit. The separation of the curves long after the treatment of Abemaciclib has finished, such that there is a 27.4% reduction in risk of recurrence and an absolute difference at seven years of 6.9%.1,7
This is the trial with the longest follow up for a CDK 4/6 inhibitor in early breast cancer, confirming that two years of treatment provides seven years of sustained clinical benefits, including overall survival.1,2,5It's important that patients stay on study for the two years that they take treatment, and in some patients that may require a reduction in dose to manage adverse events. 1,2,7,13,14,15
Reference: 1. Johnston S, Martin M, O’Shaughnessy J, et al. Ann Oncol. 2025. DOI: 10.1016/j.annonc.2025.10.005 2. Rastogi P, et al. J Clin Oncol. 2024;42(9):987-93 3. Delgado A, Guddati AK. Am J Cancer Res. 2021;11(4):1121-31. 4. Untch M, et al. Eur J Cancer. 2024;202:113977. 5. Hortobagyi GN, et al. Ann Oncol. 2025;36(2):149-57. 6. Ribociclib. Summary of Product Characteristics. April 2025. 7. Ramiven India Prescribing Information, Literature revised: 6 July 2023, Version Control No. PA008SPIN05 8. Cheng L, et al. Cancer Epidemiol Biomarkers Prev. 2012;21(5):800-9. 9. Johnston SRD, et al. J Clin Oncol. 2020;38(34):3987-98. 10. Harbeck N, et al. Ann Oncol. 2021;32(12):1571-81. 11. Tolaney SM, et al. SABCS 2024. Poster P1-11-02, Abstract 1880. 12. Zambelli A, et al. Crit Rev Oncol Hematol 2023;191:104104 13. Freedman RA, et al. J Clin Oncol. 2024;42(18):2233-5. 14. Loibl S, et al. Ann Oncol. 2024;35(2):159-82. 15. Curigliano G, et al. Ann Oncol. 2023;34(11):970-86.
PP-AL-IN-1823 | 05/01/2026
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