Results of MONALEESA-7 trial for Kisqali treatment for advanced breast cancer

Novartis announced results from the Phase III MONALEESA-7 trial in premenopausal or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer demonstrating Kisqali (ribociclib) in combination with an aromatase inhibitor or tamoxifen and goserelin as initial endocrine-based therapy significantly prolonged progression-free survival (PFS) compared to endocrine therapy and goserelin alone.

These data will be presented as a late-breaker oral presentation at the 2017 San Antonio Breast Cancer Symposium (SABCS) (Abstract #S2-05).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 (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 alone.

MONALEESA-7 trial evaluated Kisqali in combination with tamoxifen and an aromatase inhibitor. This 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 (median PFS of 22.1 vs 11.0 months; HR=0.585; 95% CI: 0.387-0.884). Kisqali in combination with an aromatase inhibitor demonstrated an additional 14 months progression-free survival over endocrine therapy alone (median PFS of 27.5 vs 13.8 months; HR=0.569; 95% CI: 0.436-0.743). Premenopausal women taking Kisqali benefited for a longer time until health-related quality of life (QoL) deterioration compared to those taking endocrine therapy alone. Women taking Kisqali also had a clinically meaningful improvement in pain symptoms as early as eight weeks; this improvement was sustained.

No new safety signals were observed in the MONALEESA-7 trial; adverse events were generally consistent with those observed in MONALEESA-2, identified early and mostly managed through dose interruptions or reductions. Combination treatment with Kisqali was well tolerated with a discontinuation rate due to adverse events of 3.6% compared to 3.0% in patients who received endocrine therapy alone. The most common (>=5%) grade 3/4 adverse events in patients receiving Kisqali combination therapy compared to endocrine therapy alone were neutropenia (60.6% vs 3.6%) and leukopenia (14.3% vs 1.2%).

See- Tripathy D, Sohn J, Im S, et al. First-line ribociclib or placebo combined with goserelin and tamoxifen or a non-steroidal aromatase inhibitor in premenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the randomized Phase III MONALEESA-7 trial. Presented at the San Antonio Breast Cancer Symposium (SABCS), December 6, 2017, San Antonio, Texas (abstract#S2-05).