Novartis has announced a new exploratory subgroup analysis of the Phase III MONALEESA-3 and MONALEESA-7 trials, reinforcing the overall survival (OS) benefit of Kisqali® (ribociclib) in HR+/HER2- advanced or metastatic breast cancer.
In this subgroup analysis, to be presented during the ASCO20 Virtual Scientific Program, Kisqali plus endocrine therapy increased OS compared to endocrine therapy alone among women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer with visceral metastases, consistent with the benefit seen in the overall study populations.
In the MONALEESA trials, where Kisqali was studied in premenopausal women in combination with NSAI plus goserelin (MONALEESA-7) and in postmenopausal women in combination with fulvestrant (MONALEESA-3), approximately 60% of the participants had visceral metastases (excluding visceral crisis), reflective of real-world clinical practice. In these patients, Kisqali in combination with endocrine therapy showed a 30% reduction in the risk of death in MONALEESA-7 trials.
In patients with liver metastases, Kisqali combination therapy showed a 47% reduction in the risk of death in MONALEESA-7, and a 37% reduction in the risk of death in MONALEESA-3 trials.
Dr Denise Yardley, Principal Investigator, Sarah Cannon Research Institute, said: “Patients with visceral metastases generally face worse prognosis and a higher risk for treatment resistance, so the consistent overall survival results with Kisqali combination therapy for these patients is compelling.”
Susanne Schaffert, PhD, President, Novartis Oncology, said: “Superior overall survival with Kisqali is proven in two phase III trials, and this subgroup analysis shows that Kisqali could make a difference in survival even among patients with the most aggressive forms of advanced breast cancer.”