Positive primary endpoint data from Novartis’ pivotal Phase III NATALEE trial has been presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
Data showed that Kisqali (ribociclib) plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.2% in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.
There was a consistent, clinically meaningful invasive disease-free survival (iDFS) benefit across key pre-specified subgroups.
Kisqali data across all secondary efficacy endpoints was also consistent, including distant disease-free survival (DDFS) (26% risk reduction) and recurrence-free survival (RFS) (28% risk reduction), with a trend for improvement in overall survival (OS).
“These landmark results will fundamentally change how we treat patients with stage II and III HR+/HER2- early breast cancer who are in need of new, well-tolerated options that prevent their cancer from coming back,” said Dennis Slamon, Director of Clinical/Translational Research, UCLA Jonsson Comprehensive Cancer Center and Chairman and Executive Director of Translational Research In Oncology (TRIO) and NATALEE trial lead investigator.
“Addressing this unmet need across such a broad patient population could help streamline treatment decisions for healthcare providers and keep many more at-risk patients cancer-free without disrupting their daily lives.”
The safety profile of Kisqali at 400mg was favourable, with low rates of symptomatic adverse events (AEs) and limited need for dose modifications when administered up to three years.
Fran Visco, President, National Breast Cancer Coalition, and member of the NATALEE Steering Committee, commented: “Educated patient advocate participation in all phases of research, especially in designing and implementing clinical trials, is critical to making certain patients have meaningful options, and we are grateful that Novartis welcomed our collaboration and participation in all aspects of the NATALEE trial.”