Novartis has reported positive results from the Phase III MONALEESA-7 trial of KisqaliCDK4/6 inhibitor in combination tamoxifen and an aromatase inhibitor in premenopausal or perimenopausal women with hormone-receptor positive.
The enrolled patients were also suffering from human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer and had not previously received endocrine therapy for advanced disease.
The Phase III randomised, double-blind, placebo-controlled MONALEESA-7 trial evaluated the efficacy and safety of Kisqali in combination with tamoxifen or a non-steroidal aromatase inhibitor plus goserelin versus tamoxifen or an aromatase inhibitor plus goserelinon the selected patients.
According to Novartis, the trial has established the safety and efficacy of the Kisqali combination therapy as first-line treatment for advanced breast cancer.
The Kisqali combination has also demonstrated an additional 14 months progression-free survival over endocrine therapy alone.
Perimenopausal women taking Kisqali experienced a clinically meaningful improvement in pain, as early as eight weeks of the trialand were able to sustain and maintain their health-related quality of life (QoL) for a longer period compared to those taking only endocrine therapy.
Novartis Oncology Global Drug Development head Samit Hirawat said: “Research in premenopausal advanced breast cancer is extremely limited as these women traditionally have been excluded from clinical trials or reduced to a subgroup in trials designed for their postmenopausal counterparts.
“We designed the robust MONALEESA clinical trial programme to be inclusive of all women and men with HR+/HER2- advanced breast cancer.”
The MONALEESA-7 trial includes more than 670 women aged 23 to 58 years.
The trial carried out evaluation of its first patient at eight weeks since the beginning of the study.