The European Commission (EC) has approved Kisqali (ribociclib) in combination with aromatase inhibitors (AI) for the treatment of patients with hormone receptor-positive, HER2-negative (HR+/HER2-) early breast cancer (EBC) at high risk of recurrence.
This milestone expands the use of Kisqali to include a broader patient population, potentially benefiting nearly double the number of eligible patients in Europe, including those with node-negative disease.
Approval Based on Pivotal NATALEE Trial Results
The decision is backed by data from the Phase III NATALEE study, which evaluated Kisqali with adjuvant endocrine therapy (ET) in a diverse group of patients with stage II and III HR+/HER2- EBC. The trial demonstrated a significant 25.1% reduction in the risk of invasive disease recurrence when Kisqali was added to ET compared to ET alone. This benefit was consistent across all patient subgroups, highlighting its potential to address the needs of a wide range of EBC patients.
Addressing Recurrence in Early Breast Cancer
Despite treatment with ET, over one-third of patients diagnosed with stage II or III EBC experience cancer recurrence, often progressing to incurable advanced stages. With its expanded indication, Kisqali offers a new option to reduce the risk of disease returning, providing hope for better outcomes in this challenging patient group.
Details of the NATALEE Study
NATALEE is a global Phase III, randomized, open-label trial involving 5,101 adult participants from 20 countries. The study assessed the efficacy and safety of Kisqali combined with ET compared to ET alone in patients with stage II and III HR+/HER2- EBC. Participants in both treatment arms received a non-steroidal aromatase inhibitor (anastrozole or letrozole) and goserelin, when applicable. The primary endpoint of the trial was invasive disease-free survival (iDFS), evaluated using the STEEP criteria.
Recently released data from a four-year follow-up of the NATALEE trial showed a continued deepening of the iDFS benefit after the three-year treatment period. This reinforces Kisqali’s role in improving long-term outcomes for patients.
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