Novartis Korea said Kisqali (ribociclib) showed consistent recurrence risk reduction regardless of age in patients with stage 2 or 3 HR-positive, HER2-negative early breast cancer at high risk of recurrence, based on a five-year update and age subgroup analysis from the global phase 3 NATALEE trial.
Professor Im Seock-ah of Seoul National University Hospital presents the five-year update and age subgroup analysis of the phase 3 NATALEE trial on Kisqali during the Global Breast Cancer Conference 2026 at Grand Walkerhill Seoul in Seoul on April 24. (Credit: Novartis Korea)
The data were presented by Professor Im Seock-ah of Seoul National University Hospital at the Global Breast Cancer Conference 2026, held at Grand Walkerhill Seoul in Seoul on last Friday.
The analysis included 5,101 patients who were divided into those younger than 40 and those aged 40 or older. At a median follow-up of 58.4 months, about two years after completing three years of Kisqali treatment, Kisqali plus endocrine therapy improved invasive disease-free survival in both groups compared with endocrine therapy alone.
In patients younger than 40, Kisqali combination therapy reduced the risk of invasive disease progression or death by 33 percent compared with endocrine therapy alone, Novartis Korea said. The absolute improvement in five-year invasive disease-free survival was 4.9 percentage points in the under-40 group and 4.4 percentage points in the 40-or-older group.
The company said patient-reported outcomes showed no meaningful decline in health-related quality of life, while the safety profile remained consistent with previous Kisqali data.
“This five-year follow-up subgroup analysis is meaningful because it shows that Kisqali’s clinical efficacy was consistently maintained in both patients younger than 40 and those aged 40 or older,” Im said. “Considering that Korea has a relatively high proportion of young patients under 40, these data are particularly noteworthy for clinical practice in Asia, including Korea.”
Kisqali was approved in Korea in 2019 for HR-positive, HER2-negative advanced or metastatic breast cancer in combination with endocrine therapy. In August 2025, the indication was expanded to adjuvant therapy for patients with stage 2 or 3 HR-positive, HER2-negative early breast cancer at high risk of recurrence.
Lee Han-soo
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