Abemaciclib Delivers New Overall Survival Data in Early Breast Cancer Patients

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

It is currently the only CDK4/6 inhibitor with a proven overall survival benefit in the curative setting following two years of adjuvant treatment.^1,2,3,4,5

At the seven-year mark, there is a 16.5% reduction in the risk of death when Abemaciclib is added to endocrine therapy, representing an absolute improvement of 2% in the cohort 1 subset of the trial population. ^1,2,3,4,5

Specific breast cancer-related deaths were reduced from 11% in the control arm to 8.3% in the Abemaciclib arm. The number of patients living with metastatic disease was significantly reduced from 9.7% to 6.5%, a trend expected to continue driving overall survival benefits over time.^1,2

The trial demonstrated a 27.4% reduction in the risk of recurrence (Invasive Disease-Free Survival, or IDFS) with an absolute improvement of 6.9% at seven years in the cohort 1 of trial population. A sustained benefit was also observed in distant relapse-free survival (DRFS), which accounts for both metastatic disease and death. ^1,5

Abemaciclib has proven long-lasting protection as shown by the longest follow up reported for a CDK4/6i in early breast cancer.^1,2,3

While 18.5% of patients discontinued treatment due to AEs, 52% of those discontinuations occurred without an appropriate dose reduction being attempted. Adverse events are described as predictable and generally reversible. Diarrhea is the most frequent AE, occurring at Grade 3 in 7.8% of patients,^6,7,8 with a typical onset of approximately 8 days and a duration of five to six days. Management strategies include prompt use of anti-diarrheal medication, increased fluid intake, dose holds, and appropriate dose reductions.^7,8

Crucially, data shows that IDFS and DRFS benefits are maintained even if a patient requires a dose reduction to manage AEs. Real-world evidence from the Flatiron database indicates that 93% of patients who underwent a dose reduction were able to successfully continue therapy beyond three months.^6,9,10 Due to these findings, Abemaciclib is the recommended treatment of choice for high-risk patients across all major international guidelines, including American Society of Clinical Oncology (ASCO),¹¹ National Comprehensive Cancer Network (NCCN),² European Society of Medical Oncology (ESMO)¹² and strongly endorsed by the St. Gallen Consensus Panel.¹³

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. Hortobagyi GN, et al. Ann Oncol. 2025;36(2):149-57. 4. Ribociclib. Summary of Product Characteristics. April 2025. 5.Ramiven India Prescribing Information, Literature revised: 6 July 2023, Version Control No. PA008SPIN05 6. Goetz MP, et al. NPJ Breast Cancer. 2024;10(1):34 (+Suppl. Appendix). 7. Johnston SRD, et al. Lancet Oncol. 2023;24(1):77-90. 8. Rugo HS, et al. Ann Oncol. 2022;33(6):616-27. 9. Hudson K, et al. San Antonio Breast Cancer Symposium (SABCS) 47th Annual Meeting; December 10-14, 2024; San Antonio, TX. 2025. 10. Ma X, et al. Comparison of Population Characteristics in Real-World Clinical Oncology Databases in the US: Flatiron Health, SEER, and NPCR. 2020 [Cited: 2025 September 24]. Available from: URL: https://www.medrxiv.org/content/10.1101/2020.03.16.20037143v3. 11. Freedman RA, et al. J Clin Oncol. 2024;42(18):2233-5. 12. Loibl S, et al. Ann Oncol. 2024;35(2):159-82. 13. Curigliano G, et al. Ann Oncol. 2023;34(11):970-86.a

PP-AL-IN-1822 | 05/01/2026

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