On December 9, 2025 Novartis reported results showing that one in four patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) remained progression-free for four or more years following treatment with Kisqali (ribociclib) plus endocrine therapy (ET)1. Results were from a pooled, post-hoc exploratory analysis of first-line patients in the MONALEESA trials and will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on December 11, 2025.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Metastatic breast cancer is cancer that has spread beyond the breasts to other parts of the body. Long-term progression-free survival benefit with Kisqali was observed in patients regardless of their menopausal status and was achieved even in a proportion of patients with unfavorable prognostic factors (liver involvement, ≥ 3 metastatic sites)1. Patients had a median progression-free survival of 6.8 years1. The median overall survival was not estimable.
Kisqali has demonstrated statistically significant overall survival (OS) across all three Phase III MONALEESA trials2-12.
"The latest MONALEESA analysis shows that 1 in 4 patients with metastatic disease remained progression-free for four years or more. Our biomarker analyses demonstrate clinical and genomic factors potentially associated with these outstanding responses, highlighting the importance of precision medicine in identifying which patients may derive the greatest benefit from CDK4/6 inhibitors," said Dr. Pedram Razavi, Breast Medical Oncologist and Director of Translational Oncology Partnership Program at Memorial Sloan Kettering Cancer Center, who is the author and presenter of the analysis at SABCS.
"Kisqali continues to deliver on its promise of potentially offering more time for people living with advanced breast cancer," said Mark Rutstein, Global Head of Oncology Development at Novartis. "The results from the long-term analysis provide continued confidence in the clinical benefit of Kisqali for metastatic breast cancer patients."
Patient and Biomarker Characteristics Associated with Long-Term Response
The post-hoc exploratory analysis of the MONALEESA-2, -3 and -7 trials in first-line HR+/HER2- MBC aimed to identify clinical characteristics and biomarkers of patients who experienced long-term response with Kisqali1.
Characteristic Long-term
Responders (LTR)
(n=153) Non-LTR
(n=349) Directional insight
Median age (years) 59.3 58.0 Comparable across groups
Postmenopausal (%) 78 78 Balanced by menopausal status
De novo disease (%) 43 40 Similar baseline disease presentation
≥ 3 metastatic sites (%) 30 43 Fewer high-burden cases among LTRs
Liver involvement (%) 16 26 Less frequent among LTRs
Bone-only disease (%) 24 20 Slightly more common among LTRs
Mean ctDNA fraction 0.05 0.13 Lower circulating tumor DNA in LTRs
CCND1 alteration (%) 2 10 Less frequent among LTRs
TP53 alteration (%) 3 12 Less frequent among LTRs
Luminal A subtype (%) 38 25 Higher prevalence among LTRs
NATALEE 5-year Data Reinforce Sustained Benefit in Reducing Distant Recurrence
Additionally, Novartis is presenting a sub-analysis from the five-year NATALEE trial that showed Kisqali plus a nonsteroidal aromatase inhibitor (NSAI) continues to result in improved distant disease-free survival (DDFS) compared to NSAI alone13. This was consistent across key subgroups with node-positive and node-negative disease, reinforcing Kisqali plus NSAI as a treatment option to help reduce the risk of recurrence for the broadest population of HR+/HER2- early breast cancer (EBC) patients.
(Press release, Novartis, DEC 9, 2025, View Source [SID1234661316])