Novartis Kisqali® reduces risk of recurrence in younger patients with early breast cancer in NATALEE subgroup analysis

Core Insights - Novartis announced new data from the Phase III NATALEE trial, highlighting the efficacy and safety of Kisqali (ribociclib) combined with endocrine therapy in patients with high-risk early breast cancer [1][8] - The trial results indicate consistent reductions in recurrence risk across various patient demographics, particularly benefiting pre-menopausal and younger patients [2][5] Efficacy and Safety - At a median follow-up of 44.2 months, Kisqali demonstrated a 33% reduction in the relative risk of invasive disease in pre-menopausal patients compared to those receiving endocrine therapy alone [5] - The hazard ratios for invasive disease-free survival (iDFS), distant disease-free survival (DDFS), and recurrence-free survival (RFS) were 0.671, 0.655, and 0.641 for pre-menopausal patients, respectively [2][3] - Discontinuation rates due to adverse events were lower in pre-menopausal patients (16.1%) compared to post-menopausal patients (22.9%) [2][3] Patient Demographics and Outcomes - The analysis revealed that younger and Black patients often present with more aggressive disease characteristics and have worse treatment outcomes compared to their white counterparts [4][5] - The findings underscore the need for improved care strategies for vulnerable populations, particularly those with high-risk early breast cancer [7] Ongoing Research and Development - Novartis is expanding its research on Kisqali's efficacy across diverse patient populations, including a new study (Adjuvant WIDER) that aims to reflect real-world demographics [6][8] - The company continues to advocate for early detection and effective treatment options to reduce recurrence risks in breast cancer patients [15]