Late-breaking NATALEE subgroup analysis to be presented at ESMO shows invasive disease-free survival (iDFS) benefit remains consistent in all subgroups, including in patients with stage II tumors, node-negative disease and those who are 65 or older1

The data reinforce previously presented results which reported that investigational use of Kisqali® (ribociclib) plus endocrine therapy (ET) significantly lowered the risk of cancer recurrence across a broad population of patients with stage II and III HR+/HER2- early breast cancer (EBC), while also maintaining patients’ quality of life in the adjuvant setting1,2,3

The outcomes of patients treated with ET alone in this NATALEE analysis confirm an unmet need across all study subgroups, including patients with node-negative or stage II disease1

Basel, October 20, 2023 — Novartis will present late-breaking results from a prespecified exploratory subgroup analysis of invasive disease-free survival (iDFS) from the pivotal Phase III NATALEE trial at the European Society for Medical Oncology (ESMO) Congress 2023. After 27.7 months of follow-up, the iDFS benefit with Kisqali® (ribociclib) plus endocrine therapy (ET) was consistent across key prespecified subgroups, compared to ET alone, in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) (see table below)1. Results were also consistent with those in the overall trial population, reinforcing that the benefit was not driven by a specific patient subgroup1,2.

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https://www.novartis.com/news/media-releases/novartis-kisqali-natalee-analysis-reinforces-consistent-reduction-risk-recurrence-across-key-subgroups-patients-early-breast-cancer