Novartis Presents ASCO Data Showing Kisqali’s Efficacy and Tolerability in High-Risk Early Breast Cancer Patients

Novartis Presents ASCO Data Showing Kisqali’s Efficacy and Tolerability in High-Risk Early Breast Cancer Patients

(IN BRIEF) Novartis has presented new data from the Phase III NATALEE trial at ASCO 2025, showcasing Kisqali’s ability to reduce the risk of recurrence in pre-menopausal patients with high-risk early breast cancer. The data reveals a 33% reduction in the relative risk of invasive disease for pre-menopausal patients receiving Kisqali in combination with endocrine therapy, with fewer treatment discontinuations due to adverse events. In addition to efficacy results, a real-world analysis highlighted the critical need to improve care for Black patients, who were found to have worse outcomes in comparison to white patients. Kisqali continues to demonstrate efficacy and tolerability as a treatment option for early breast cancer patients at high risk of recurrence.

(PRESS RELEASE) BASEL, 2-Jun-2025 — /EuropaWire/ — Novartis has announced new data from a subgroup analysis of the Phase III NATALEE trial, presented today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, evaluating the efficacy and safety of Kisqali® (ribociclib) in combination with endocrine therapy (ET) for pre- and post-menopausal patients with high-risk stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC). This new data highlights Kisqali’s ability to reduce the risk of invasive disease in pre-menopausal patients, showing a 33% reduction in relative risk of invasive disease during a one-year post-treatment analysis. Importantly, the data also demonstrates that pre-menopausal patients experienced fewer treatment discontinuations due to adverse events (AEs) compared to their post-menopausal counterparts.

The Phase III NATALEE trial showed that Kisqali consistently reduced the risk of recurrence across all efficacy measures, including invasive disease-free survival (iDFS), distant disease-free survival (DDFS), and recurrence-free survival (RFS), irrespective of age and menopausal status. In the one-year post-treatment analysis, pre-menopausal patients saw greater reductions in risk and a significantly lower rate of discontinuation due to AEs, reinforcing the value of Kisqali as a well-tolerated treatment for high-risk EBC patients.

Dr. Kevin Kalinsky, Division Director of Medical Oncology and Director of the Glenn Family Breast Center at Winship Cancer Institute of Emory University, commented, “It is encouraging to see that Kisqali continues to deliver durable risk reduction for a broad population of patients, especially younger patients who often face more aggressive disease. The lower rates of discontinuation due to AEs strengthen the case for Kisqali as an effective and tolerable intervention for patients seeking to reduce the likelihood of their cancer coming back.”

In addition to the efficacy findings, the NATALEE trial also presented a separate real-world analysis at ASCO, highlighting disparities in treatment outcomes for Black patients with EBC. This analysis found that Black patients were more likely to be younger, pre-menopausal, and have more extensive disease than their white counterparts. After adjusting for these factors, Black patients were observed to have worse RFS, DDFS, and overall survival, underscoring the critical need to improve care and support for these vulnerable populations through the addition of CDK4/6 inhibitors like Kisqali to their adjuvant treatment regimen.

Novartis is also continuing to explore the efficacy and safety of Kisqali through ongoing trials, such as the Adjuvant WIDER study, which is enrolling patients that closely reflect the diverse population seen in clinical practice, including more patients from racial and ethnic minority groups.

Reshema Kemps-Polanco, Executive Vice President and Chief Commercial Officer at Novartis US, said, “There is an undeniable and urgent need to improve outcomes for vulnerable patient populations, including younger and Black patients, who often face more aggressive forms of breast cancer. Kisqali provides an opportunity to significantly reduce the risk of recurrence for these patients, while continuing to offer survival benefits to patients with metastatic disease.”

About NATALEE
NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali with ET as an investigational adjuvant treatment versus ET alone in patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO5,6. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable5,6. The primary endpoint of NATALEE is invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria5,6. A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial5,6.

About Kisqali® (ribociclib)
Kisqali® (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.

Kisqali has been approved as a treatment for breast cancer by regulatory authorities in 99 countries worldwide, including the U.S. FDA and the European Commission7,8. In the US, Kisqali is indicated in combination with an AI as an adjuvant treatment for adults with HR+/HER2- stage II and III early breast cancer at high risk of recurrence, as well as for the treatment of adults with HR+/HER2- advanced or MBC as initial ET; Kisqali is also approved in the metastatic indication in combination with fulvestrant as initial ET or following disease progression on ET7. In the EU, Kisqali is approved in combination with an AI for the adjuvant treatment of patients with HR+/HER2- early breast cancer at high risk of recurrence; and for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression8. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist7,8.

In EBC, ribociclib (Kisqali) is the only CDK4/6 inhibitor recommended by the NCCN Guidelines® for breast cancer for both all node-positive disease as well as for patients with no nodal involvement with high-risk disease characteristics, such as tumor size >5 cm, or for tumors sized 2-5 cm, either Grade 2 with high genomic risk/Ki-67 ≥20% or Grade 39. Kisqali approvals in EBC from regulatory authorities worldwide are ongoing, including recent approval from China’s National Medical Products Administration10. In MBC, Kisqali has consistently demonstrated statistically significant overall survival benefit across three Phase III trials11-21. The NCCN Guidelines® also recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of people living with HR+/HER2- MBC when combined with an AI9, making Kisqali the preferred first-line treatment of choice for US prescribers in HR+/HER2- MBC.

In addition, Kisqali has achieved the highest score (A) on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for EBC22; and has the highest rating of any CDK4/6 inhibitor on the ESMO Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line pre-menopausal patients with HR+/HER2- advanced breast cancer23. Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR+/HER2- advanced breast cancer treated in the first line24.

Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals.

Please see full Prescribing Information for Kisqali, available at www.Kisqali.com.

About Novartis in Breast Cancer
For more than 30 years, Novartis has been at the forefront of driving scientific advancements for people touched by breast cancer and improving clinical practice in collaboration with the global community. With one of the most comprehensive breast cancer portfolios and pipeline, Novartis leads the industry in the discovery of new therapies and combinations in HR+/HER2- breast cancer, the most common form of the disease. Beyond medicines, Novartis is leading efforts to encourage early detection and working to remove access barriers faced by patients along their care journey.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

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References

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SOURCE: Novartis