Yahoo Finance Novartis' Kisqali Lowers Risk of Breast Cancer Recurrence by 28%
Novartis NVS announced positive data on breast cancer drug Kisqali (ribociclib) from the late-stage study, NATALEE.
This late-breaking data from this four-year post-hoc analysis was presented at the European Society for Medical Oncology (“ESMO”) Congress 2024.
Data showed that Kisqali, when added to endocrine therapy (ET), reduced the risk of disease recurrence by 28.5% in a broad population of patients with early breast cancer (EBC). Shares of NVS rose 1% on the news.
Year to date, shares of Novartis have risen 15.8% compared with the industry’s growth of 26%.
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NVS’ Kisqali Shines in Phase III
Kisqali has been approved as a treatment for metastatic breast cancer (MBC) in several countries.
NATALEE, a global phase III multi-center, randomized, open-label study, is evaluating the efficacy and safety of Kisqali with ET as an investigational adjuvant treatment versus ET alone in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) EBC.
Results showed that Kisqali, when added to ET, demonstrated a deepening benefit beyond the three-year treatment period, reducing the risk of recurrence by 28.5% compared to ET alone, in the targeted patient population.
This invasive disease-free survival (iDFS) benefit was also consistent across all pre-specified patient subgroups, including those with node-negative disease.
Results remain consistent across secondary endpoints, including distant disease-free survival, with a trend for improved overall survival (OS).
The results underscore Kisqali’s potential in treating EBC as there is a substantial risk of cancer coming back as metastatic disease for patients diagnosed with HR+/HER2- EBC.
These results were based on overall survival data at 4-year post-hoc analysis. An additional follow-up has been planned to obtain more mature OS data.
Novartis submitted data from the NATALEE study to the FDA and European Medicines Agency in 2023. A regulatory action from the FDA is expected in the third quarter.
Kisqali: A Top Drug for NVS
Kisqali is one of the key growth drivers for NVS, which is now a pure-play innovative medicine company with a focus on core therapeutic areas — cardiovascular, renal and metabolic, immunology, neuroscience and oncology. It is one the leading breast cancer drugs in the United States and outside the country with a dominant market share. The drug generated sales worth $1.3 billion in the first half of 2024.
A potential approval of the drug for a broader population should further fuel sales.
Novartis’ performance in the first half was impressive. The rise in operating income guidance, along with robust second-quarter results, indicates strong momentum across all key brands in the upcoming quarters.
NVS’ Zacks Rank & Other Stocks to Consider
NVS currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the large cap pharma industry are Eli Lilly LLY, Bayer BAYRY and Pfizer PFE. While NVS sports a Zacks Rank #1 (Strong Buy) at present, BAYRY and PFE carry a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Eli Lilly’s 2024 earnings have risen from $15.77 to $16.49 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $22.79 to $23.97 over the same time frame. Year to date, Lilly’s shares have risen 58.4%.
Estimates for BAYRY’s 2024 earnings have risen from $1.35 to $1.38 per share over the past 60 days. For 2025, the bottom-line estimate has risen from $1.42 to $1.44 over the same time frame.
Estimates for PFE’s 2024 earnings have risen from $2.39 to $2.62 per share over the past 60 days. For 2025, the bottom-line estimate has risen from $2.75 to $2.85 over the same time frame.
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