Kefah Mokbel, Professor of Medicine (Honorary) at Cardiff University School of Medicine, shared a post on LinkedIn:
“Breaking Update: 4-Year Results from the NATALEE Trial
The NATALEE randomized clinical trial has released its 4-year exploratory analysis in JAMA Oncology (2025), evaluating adjuvant ribociclib plus endocrine therapy in HR-positive/HER2-negative early breast cancer.
Key findings:
- Invasive Disease-Free Survival (iDFS): Ribociclib + NSAI sustained its benefit over NSAI alone, with 4-year iDFS rates of 88.5% vs 83.6% (HR 0.72).
- Durable Benefit: The absolute benefit grew over time (3-year difference 2.7%, 4-year difference 4.9%).
- Consistency Across Subgroups: Benefit observed across patient subsets and secondary endpoints.
- Safety: Adverse event profile remained stable.
- Overall Survival: Still immature, but an early trend favors ribociclib.
Context matters: While ribociclib demonstrates durable iDFS benefit, abemaciclib has already shown an overall survival benefit at 7 years in the monarchE trial. Together, these findings shape the evolving role of CDK4/6 inhibitors in the adjuvant treatment of early breast cancer.”
Title: Ribociclib Plus Endocrine Therapy in Hormone Receptor–Positive/ERBB2-Negative Early Breast Cancer4-Year Outcomes From the NATALEE Randomized Clinical Trial
Authors: Qeter A. Fasching, Daniil Stroyakovskiy, Denise A. Yardley, Chiun-Sheng Huang, John Crown, Aditya Bardia, Stephen Chia, Seock-Ah Im, Miguel Martin, Binghe Xu, Sherene Loi, Carlos Barrios, Michael Untch, Rebecca Moroose, Frances Visco, Gabriel N. Hortobagyi, Dennis J. Slamon, Rodrigo Fresco, Juan Pablo Zarate, Zheng Li, Sorcha Waters, Sara A. Hurvitz
Read the Full Article on JAMA Oncology
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