Novartis(US:NVS) Globenewswire·2025-12-09 12:15Core Insights - Novartis announced that one in four patients with HR+/HER2- advanced breast cancer remained progression-free for four or more years after treatment with Kisqali plus endocrine therapy [1][4] - The median progression-free survival for patients treated with Kisqali was reported at 6.8 years, with significant long-term benefits observed across various patient demographics [2][5] Patient and Biomarker Characteristics - The analysis identified characteristics associated with long-term responders, including a lower frequency of liver involvement (16% in long-term responders vs. 26% in non-responders) and fewer patients with three or more metastatic sites (30% vs. 43%) [6][8] - Long-term responders had a mean circulating tumor DNA (ctDNA) fraction of 0.05 compared to 0.13 in non-responders, indicating a potential biomarker for treatment response [8] Clinical Trial Results - Kisqali has shown statistically significant overall survival across all three Phase III MONALEESA trials, reinforcing its efficacy in treating metastatic breast cancer [3][7] - The NATALEE trial's five-year data demonstrated sustained improvement in distant disease-free survival when Kisqali was combined with a nonsteroidal aromatase inhibitor, supporting its use in early breast cancer patients [9] Regulatory and Clinical Position - Kisqali is approved in over 100 countries, including the U.S. and Europe, for various indications in HR+/HER2- breast cancer, making it a preferred treatment option [12][13] - The drug has received high ratings on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale, indicating its strong clinical benefit in both early and advanced breast cancer settings [14]