Novartis announces positive results from phase 3 trial of Kisqali for early breast cancer
pharmafile | March 27, 2023 | News story | Research and Development |
Novartis has announced positive results from its phase 3 NATALEE trial assessing Kisqali (ribociclib) along with endocrine therapy (ET) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) at risk of recurrence.
The trial’s primary endpoint of invasive disease-free survival (iDFS) was met, meaning the trial was allowed to stop early. Kisqali with ET was proven to significantly reduce the risk of disease recurrence when compared with standard adjuvant ET alone.
The results of this trial follow previous data showing that Kisqali also demonstrated overall survival benefit in patients with metastatic breast cancer (MBC) while also improving or maintaining quality of life.
Dennis J Slamon, MD, director of Clinical/Translational research at University of California, Los Angeles Jonsson Comprehensive Cancer Center, chairman and executive director of Translational Research in Oncology (TRIO) and NATALEE trial lead investigator, commented: “While most patients are diagnosed and treated early with the aim to cure breast cancer, the risk of cancer returning, often as metastatic disease, peaks within three years after diagnosis, but never goes away completely. There is a critical need for new, well-tolerated options that keep patients cancer-free without disrupting quality of life. The NATALEE trial, where ribociclib was given for three years plus ET, was designed with these unmet needs in mind, and it is extremely encouraging that this study met its primary endpoint.”
Shreeram Aradhye, MD, president of Global Drug Development and chief medical officer at Novartis, added: “The positive topline results from NATALEE represent a major milestone in our ambition to expand the benefits of Kisqali to patients with earlier stages of breast cancer, building on the heritage of this effective treatment in HR+/HER2- metastatic breast cancer. This data has the potential to be paradigm-shifting for patients at risk of recurrence, including those with no nodal involvement, who have limited well-tolerated options to prevent recurrence. Our teams are working on submissions to health authorities around the world with the hope to bring Kisqali to many more patients diagnosed with breast cancer.”
Betsy Goodfellow
