Novartis announces data from new subgroup analysis of Phase III NATALEE trial
Novartis (NVS) is announcing data from a new subgroup analysis of the Phase III NATALEE trial evaluating the efficacy and safety of Kisqali plus endocrine therapy in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative early breast cancer, EBC, at high risk of recurrence across age and menopausal status. The data will be presented at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting. Results at median follow-up of 44.2 months show that patients receiving Kisqali continued to see consistent reductions in risk of recurrence across all efficacy measures, regardless of age and menopausal status. In this one-year post-treatment analysis, pre-menopausal and younger patients, who often present with more aggressive disease characteristics, experienced greater reductions in risk of recurrence and fewer treatment discontinuations due to adverse events than post-menopausal patients. Results include: 33% reduction in relative risk of invasive disease observed in pre-menopausal early breast cancer patients receiving Kisqali in 1-year post-treatment analysis; Tolerability remained consistent, with fewer treatment discontinuations due to adverse events among pre-menopausal patients; Separate real-world analysis presented at ASCO demonstrates differences in treatment outcomes that underscore critical need to improve care for Black patients with EBC.
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