Novartis Reports Positive Results from Phase III Trial of Kisqali

Novartis announced positive topline results from the global MONALEESA-7 trial, the second Phase III trial of Kisqali (ribociclib) in advanced or metastatic breast cancer. The MONALEESA-7 trial met its primary endpoint of progression-free survival (PFS) in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.

MONALEESA-7 is the first prospective global Phase III trial in more than 20 years, designed specifically for premenopausal women diagnosed with advanced breast cancer, to demonstrate superiority of any CDK4/6 inhibitor in combination with oral hormonal therapies and goserelin versus endocrine treatment alone in this patient population.

“There remains a significant unmet treatment need in younger women diagnosed with premenopausal advanced breast cancer, as the disease tends to be more aggressive with a poorer prognosis,” said Samit Hirawat, Executive Vice President and Head, Global Drug Development at Novartis Oncology. “The MONALEESA-7 trial is the first CDK 4/6 inhibitor Phase III trial designed specifically for this patient population, and we are excited that the study met its primary endpoint, which may allow us to expand the population of patients who can benefit from treatment with Kisqali. We look forward to presenting MONALEESA-7 study data at SABCS next month and discussing these results with regulatory agencies worldwide.”

MONALEESA-7 is a Phase III randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Kisqali in combination with oral hormonal therapies and goserelin versus endocrine treatment alone in premenopausal or perimenopausal women with HR+/HER2- advanced breast cancer who had not previously received endocrine therapy for advanced disease. More than 670 women ranging from 25-58 years in age were randomized in the MONALEESA-7 trial.

No additional safety signal was identified in the MONALEESA-7 study[1]. Results of MONALEESA-7 trial will be presented at the 40^th annual San Antonio Breast Cancer Symposium (SABCS) in December. Novartis plans to begin discussions with global health authorities worldwide.