Novartis gets CHMP approval for Kisqali® to reduce HR+/HER2- early breast cancer recurrence risk

A new development in the treatment of early breast cancer in Europe has emerged, offering hope for patients at high risk of recurrence. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the marketing authorization for Kisqali® (ribociclib) as an adjuvant treatment. This recommendation applies to adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease.

The recommendation is based on the findings from the Phase III NATALEE trial. This pivotal study demonstrated that adding Kisqali to endocrine therapy (ET) significantly reduced the risk of cancer recurrence by 25%, compared to ET alone. The trial involved a broad population of patients with stage II and III HR+/HER2- early breast cancer. The data showed a consistent, clinically meaningful invasive disease-free survival (iDFS) benefit across key subgroups of patients.

Dr. Peter A. Fasching, a professor of translational medicine at the University Hospital Erlangen and a NATALEE trial investigator, highlighted the significance of this development. He noted that a substantial number of patients diagnosed with stage II or III breast cancer experience cancer recurrence over the long term, often as metastatic disease. Dr. Fasching emphasized that Kisqali could offer an effective and tolerable adjuvant treatment option, particularly for patients with limited treatment alternatives, including those with high-risk node-negative disease.

Breast cancer remains the most frequently diagnosed cancer in Europe, with HR+/HER2- being the most common subtype, accounting for approximately 70% of all breast cancer cases. Over 40% of HR+/HER2- breast cancers are diagnosed at stage II or III, underscoring the need for effective treatments to prevent recurrence.

The CHMP's positive decision was informed by robust data from the NATALEE trial, which showed that Kisqali plus ET lowered the risk of cancer recurrence by 25.1% in patients with stage II and III HR+/HER2- EBC. The trial's safety profile indicated that Kisqali, at a 400mg dose, was well-tolerated with generally low-grade symptomatic adverse events.

An updated analysis from the NATALEE trial, presented at the European Society for Medical Oncology (ESMO) Congress 2024, further supports the potential of Kisqali to reduce the risk of recurrence across a broad population. The data revealed that the iDFS benefit continued to improve beyond the three-year Kisqali treatment period in all patient subgroups, including those with node-negative disease.

Dr. Patrick Horber, President of International at Novartis, highlighted that many individuals diagnosed with HR+/HER2- early breast cancer in Europe currently lack options beyond endocrine therapy to reduce the risk of recurrence. If approved, Kisqali could nearly double the number of patients eligible for CDK4/6 inhibitor adjuvant therapy, offering a new treatment option for a broad patient population.

Following the CHMP's recommendation, the European Commission (EC) is expected to make a final decision within approximately two months.

The NATALEE trial is a global Phase III multi-center, randomized, open-label study that evaluates the efficacy and safety of Kisqali in combination with ET versus ET alone in patients with stage II and III HR+/HER2- EBC. Conducted in collaboration with TRIO, the trial involved 5,101 adult patients across 20 countries.

Kisqali, a selective cyclin-dependent kinase inhibitor, helps slow the progression of cancer by targeting CDK4/6 proteins. It was approved by the FDA for early breast cancer treatment in September 2024, and regulatory reviews are ongoing worldwide, including in the EU and China.

Kisqali has also been approved as a treatment for metastatic breast cancer (MBC) in 99 countries. In the US, it is indicated for HR+/HER2- advanced or MBC in combination with an aromatase inhibitor or fulvestrant. In the EU, it is approved for HR+/HER2- advanced or MBC in combination with either an aromatase inhibitor or fulvestrant. Kisqali has consistently demonstrated significant overall survival benefits in Phase III trials, earning high ratings on the ESMO Magnitude of Clinical Benefit Scale.

Novartis continues to drive scientific advancements and collaborate with the global community to improve outcomes for breast cancer patients.