Novartis says a new exploratory subgroup analysis of the Phase III MONALEESA-3 and MONALEESA-7 trials reinforce the overall survival (OS) benefit of Kisqali (ribociclib) in breast cancer.

In this analysis, 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), around 60% of the participants had visceral metastases, 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 and a 20% reduction in the risk of death in MONALEESA-3.

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.

“The analysis, looking across two Phase III trials, supports the use of Kisqali in the first-line setting regardless of menopausal status or metastatic location,” said Denise Yardley, MD, Principal Investigator, Sarah Cannon Research Institute.

“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.”

The data is to be presented during the ASCO20 Virtual Scientific Programme.