Positive topline results for Novartis’ Kisqali

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Novartis has reported positive results from the Phase III trial of Kisqali® (ribociclib) combination therapy in premenopausal women with HR+/HER2- advanced or metastatic breast cancer.

The global MONALEESA-7 trial met the 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, demonstrating superior efficacy of Kisqali combination therapy vs. endocrine treatment alone in first-line treatment of those women.

MONALEESA-7 is the first prospective global Phase III trial in more than two decades, 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.

The randomised, 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 randomised in the trial. No additional safety signal was identified in the study.

Samit Hirawat, Executive Vice President and Head, Global Drug Development at Novartis Oncology, said: “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.

“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.”

Results will be presented at the 40th annual San Antonio Breast Cancer Symposium in December. Novartis plans to begin discussions with global health authorities worldwide.