Novartis’ Kisqali (ribociclib) combination therapy has succeeded in a phase 3 study in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
The trial known as MONALEESA-7 met its primary endpoint of progression-free survival (PFS), stated Novartis.
Through the late-stage trial, the CDK4/6 inhibitor Kisqali in combination with oral hormonal therapies and goserelin was demonstrated to be superior in comparison to endocrine treatment alone.
Over 670 premenopausal or perimenopausal women with HR+/HER2- advanced breast cancer, who did not receive any prior endocrine therapy for their advanced disease, and in the age group of 25-58 years were randomized in the global trial.
Novartis stated that there was no additional safety signal registered during the MONALEESA-7 study.
Novartis oncology global drug development executive vice president and head Samit Hirawat 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.
“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.”
In August, Kisqali in combination with an aromatase inhibitor was approved by the European Commission as a first-line treatment in postmenopausal women with (HR+/HER2-) locally advanced or metastatic breast cancer.
Prior to that, in March, Novartis received the US Food and Drug Administration (FDA) approval for Kisqali in combination with an aromatase inhibitor as an initial endocrine-based therapy for the treatment of metastatic breast cancer.