Novartis has presented the six-year follow-up of the NATALEE trial. The combined treatment reduces the risk of death by 19.1% compared to endocrine therapy alone.
Novartis has presented the results of the six-year follow-up of the phase III NATALEE trial, which show a clinically relevant benefit in overall survival for patients with high-risk early breast cancer HR+/HER2- treated with Kisqali (ribociclib) plus endocrine therapy. The information, reported by Infosalus, details that the combination reduces the risk of death by 19.1% compared to endocrine therapy alone.
The study included patients in stages II and III with a high risk of relapse, both without lymph node involvement but with high-risk characteristics and with lymph node involvement. The results were presented at the 2026 Annual Meeting of the European Society for Medical Oncology (ESMO).
At the time of analysis, patients had a median of 38 months without treatment and had surpassed the five years of endocrine therapy planned in the protocol. The absolute benefit in invasive disease-free survival increased from 4.1% at five years to 5.3% at six years.
The absolute difference in overall survival also grew, from 1.2% at five years to 2.1% at six years. Additionally, fewer patients treated with the combination experienced metastatic relapse. Breast cancer-specific survival reflected an approximate 30% reduction in the risk of death from this disease.
“The six-year NATALEE data clearly demonstrate a clinically relevant improvement in overall survival with the combination treatment plus endocrine therapy,” stated Dennis J. Slamon, head of the Division of Hematology/Oncology at UCLA's Department of Medicine.
According to the company, the safety profile remained consistent with previous analyses, and no new safety signals were identified. Secondary primary neoplasms affected 3% of patients receiving the combined treatment and 3.3% with endocrine therapy alone.
The study is being conducted in 20 countries. In Spain, it is coordinated by the Spanish Group for Research in Breast Cancer (GEICAM), which has coordinated the trial in 47 hospitals across 12 autonomous communities. The country contributes 761 participants, 15% of the total sample, second only to the United States, with 819 patients.
“These findings demonstrate the value of combining a CDK4/6 inhibitor with endocrine therapy in the broader population of high-risk relapse patients,” highlighted Andrea Myers, global head of Oncology Development at Novartis.
For his part, Ander Urruticoechea, medical oncologist at Donostia University Hospital-Biogipuzkoa and president of GEICAM, emphasized Spain's participation in the trial.
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