Swiss pharmaceutical giant Novartis (NYSE: NVS) presented updated results from the pivotal Phase III NATALEE study for its Kisqali (ribociclib) at the 2024 San Antonio Breast Cancer Symposium (SABCS). The study provides significant insights into the efficacy of Kisqali in combination with endocrine therapy (ET) for patients with receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) who are at risk of recurrence.
NATALEE Study Design and Interim Analysis Results
The NATALEE study is designed to assess the efficacy of Kisqali in combination with ET in patients with HR+/HER2- EBC. Interim analysis results previously revealed that the study had delivered benefits in terms of the primary endpoint of invasive disease-free survival (iDFS). The four-year long-term follow-up data unveiled at SABCS demonstrated the extended efficacy of Kisqali beyond the duration of treatment in combination with ET.
Long-Term Follow-Up Data and Efficacy
Specifically, the combination therapy realized a sustained reduction in distant recurrence of 28.5% (HR=0.715; 95% CI 0.604-0.847; nominal P<0.0001), compared to ET alone, in patients with stage II and III HR+/HER2- EBC. This reduction effectively prolonged distant disease-free survival (DDFS). The DDFS benefits with Kisqali were consistent across all pre-specified patient subgroups, including those with node-negative (N0) disease. Additionally, the Kisqali/ET combination had controllable long-term adverse reactions, with an overall safety profile consistent with previous findings.
Real-World Evidence and Kisqali’s Global Impact
Real-world evidence presented at the meeting highlighted the relatively high incidence of distant recurrences within five years despite ET monotherapy for patients at high-risk, regardless of nodal involvement. Kisqali, a selective cyclin-dependent kinase4/6 (CDK4/6) inhibitor, was first approved in the US in March 2017 for first-line treatment of postmenopausal women with HR+, HER2- advanced or metastatic breast cancer when combined with an aromatase inhibitor (AI). Subsequent approvals in the European Union (EU) and China followed, with regulatory authorities from 99 countries now approving the drug as a treatment for breast cancer.-Fineline Info & Tech
