Novartis has announced results from the Phase III MONALEESA-7 trial in premenopausal or perimenopausal women with the most common form of advanced breast cancer, also known as hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer.
Kisqali® (ribociclib), in combination with an aromatase inhibitor or tamoxifen plus goserelin as initial endocrine-based therapy, demonstrated significantly prolonged progression-free survival (PFS) compared to endocrine therapy plus goserelin and placebo.
These data were presented as a late-breaker oral presentation at the 2017 San Antonio Breast Cancer Symposium.
Kisqali in combination with tamoxifen or an aromatase inhibitor plus goserelin demonstrated a median PFS of 23.8 months (95% CI: 19.2 months-not reached) compared to 13.0 months (95% CI: 11.0-16.4 months) for tamoxifen or an aromatase inhibitor plus goserelin and placebo (HR=0.553; 95% CI: 0.441-0.694; p<0.0001).
Premenopausal women treated with Kisqali combination therapy saw a response as early as eight weeks as demonstrated by separation of the PFS curves compared to endocrine therapy plus goserelin and placebo.
In the UK, around 55,000 women are diagnosed with breast cancer each year. 30% of women with earlier stages of breast cancer will develop advanced disease, which is responsible for 90% of all breast cancer-related deaths.
85% of women diagnosed with advanced breast cancer will not live longer than five years. Premenopausal breast cancer is a biologically distinct and more aggressive disease than postmenopausal breast cancer, and it is the leading cause of cancer death in women 20-59 years old.
MONALEESA-7 is the only Phase III study to evaluate a CDK4/6 inhibitor in combination with tamoxifen and establishes the safety and efficacy of Kisqali in this combination as first-line treatment for advanced breast cancer.
Professor Mark Beresford, Co-Chair of the UK Breast Cancer Group (UKBCG), which represents Clinical and Medical Oncologists treating breast cancer in the UK, said: “The results from MONALEESA-7 are impressive and pending approval for use in premenopausal or perimenopausal women in the UK, ribociclib will provide a valuable treatment option whilst allowing greater flexibility in the choice of partner endocrine therapy.”