1. Kisqali shows 25% progression-free survival for four years in advanced breast cancer. 2. Significant overall survival demonstrated across all MONALEESA Phase III trials. 3. NATALEE trial confirms Kisqali reduces distant disease recurrence in early breast cancer. 4. Long-term responses are consistent across age and menopausal status. 5. Kisqali remains a preferred CDK4/6 inhibitor in clinical guidelines for breast cancer.
FAQ
Why Bullish?
The consistent evidence of efficacy for Kisqali improves investor confidence in NVS, similar to past trends following favorable trial results.
How important is it?
NVS's leadership in breast cancer therapies indicates a strong market position, with ongoing positive clinical data adding critical leverage against competitors.
Why Long Term?
The sustained effectiveness of Kisqali for various cancer stages likely enhances long-term revenue prospects for NVS, building on established market presence.
1 in 4 Metastatic Breast Cancer Patients Treated with Novartis Kisqali® Remain Progression-Free Beyond 4 Years
Novartis has announced that approximately 25% of patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) have remained progression-free for four or more years after treatment with Kisqali® (ribociclib) in combination with endocrine therapy (ET). This significant finding will be presented at the 2025 San Antonio Breast Cancer Symposium® (SABCS) on December 11, 2025.
Long-Term Progression-Free Survival with Kisqali
The latest results stem from a pooled, post-hoc exploratory analysis of patients from the MONALEESA clinical trials. The data indicates a median progression-free survival (PFS) of 6.8 years for patients treated with Kisqali, demonstrating the treatment's efficacy across different age, body mass index (BMI), and menopausal status.
Moreover, a notable benefit was observed even among patients with poor prognostic factors, including those with liver involvement and multiple metastatic sites.
Statistically Significant Overall Survival
Kisqali is now the only CDK4/6 inhibitor to show statistically significant overall survival across all Phase III MONALEESA trials. According to Dr. Pedram Razavi, a Breast Medical Oncologist at Memorial Sloan Kettering Cancer Center, “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 linked to these outstanding responses.”
Mark Rutstein, Global Head of Oncology Development at Novartis, noted, “Kisqali continues to deliver on its promise of potentially offering more time for people living with advanced breast cancer.”
Patient Characteristics Linked to Long-Term Response
The exploratory analysis focused on identifying both patient characteristics and biomarkers that might predict long-term responses to Kisqali. The data included:
- Median age: 59.3 years for long-term responders versus 58.0 years for non-responders
- Postmenopausal status: 78% in both groups
- De novo disease: 43% in long-term responders compared to 40% in others
- ≥ 3 metastatic sites: 30% in responders compared to 43% in non-responders
- Mean ctDNA fraction: 0.05 in responders versus 0.13 in non-responders
- CCND1 alteration: 2% in responders versus 10% in non-responders
- TP53 alteration: 3% in responders versus 12% in non-responders
NATALEE 5-Year Data Strengthen Treatment Efficacy
Additionally, Novartis is set to present data from the five-year NATALEE trial, which demonstrates that Kisqali combined with a nonsteroidal aromatase inhibitor (NSAI) leads to improved distant disease-free survival (DDFS) compared to NSAI alone. This is applicable across key subgroups of early breast cancer (EBC) patients.
This analysis reinforces Kisqali's potential to reduce recurrence risks for a broad population of HR+/HER2- EBC patients, highlighting the continuing advancements in precision medicine.
About Novartis in Breast Cancer
For over three decades, Novartis has been at the forefront of advancements in breast cancer treatment. The company boasts one of the most comprehensive portfolios, aiming to discover new therapies and combinations specifically targeting HR+/HER2- breast cancer, the most prevalent form of the disease.
About Kisqali® (ribociclib)
Kisqali is a selective cyclin-dependent kinase inhibitor that slows cancer progression by inhibiting proteins CDK4 and CDK6. Approved in over 100 countries, Kisqali has shown sustained efficacy as a treatment option for both adjuvant therapy in HR+/HER2- early breast cancer and metastatic breast cancer.