Novartis presented positive primary endpoint data from the pivotal phase 3 Natalee trial with small molecule inhibitor Kisqali (ribociclib) plus endocrine therapy (ET) at the American Society of Clinical Oncology (ASCO) annual meeting.
Data showed that Kisqali plus ET, compared to ET alone, lowered the risk of cancer recurrence by 25.2% in patients with stage 2 and 3 hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.
Dennis Slamon, director of clinical/translational research in oncology and trial lead investigator, said: “These landmark results will fundamentally change how we treat patients with stage 2 and 3 HR+/HER2- early breast cancer who are in need of new, well-tolerated options that prevent their cancer from coming back.
“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.”
Kisqali data across all secondary efficacy endpoints was also consistent, including distant disease-free survival (DDFS) with a 26% risk reduction and recurrence-free survival (RFS) with a 28% risk reduction, with a trend for improvement in overall survival (OS).
The study revealed the safety profile of Kisqali at 400mg was favorable with low rates of symptomatic adverse events (AEs) and limited need for dose modifications when administered up to three years. The most frequently reported AEs of special interest at grade 3 or higher were neutropenia at 43.8% and liver-related AEs such as elevated transaminases 8.3%. Grade 3 or higher QT interval prolongation and diarrhoea were low for Kisqali at 1% and 0.6%, respectively.
Shreeram Aradhye, president of global drug development and chief medical officer at Novartis, said: “Patients diagnosed with HR+/HER2- early breast cancer remain at risk of cancer recurrence, given that one-third of patients diagnosed with stage 2 and more than half of those diagnosed with stage 3 will unfortunately experience a return of their cancer.
“The compelling data from Natalee highlight the potential of Kisqali to reduce the risk of cancer recurrence in this at-risk population, including node-negative patients, while maintaining a favorable safety profile. These potentially practice-changing results reinforce the unique and well-established profile of Kisqali as a proven treatment in HR+/HER2- metastatic breast cancer.”
Fran Visco is president of the National Breast Cancer Coalition and a member of the Natalee steering committee. He said after an early breast cancer diagnosis, patients often live with a persistent and lifelong worry that their cancer will return.
He said: “The National Breast Cancer Coalition partners with industry and scientists to help find treatments that will make certain that does not happen. 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."
Novartis plans to submit these phase 3 data to regulatory authorities in the US and Europe before end of year.