National Comprehensive Cancer Network® (NCCN®) differentiates ribociclib (KISQALI®) as the only Category 1 Preferred first-line treatment option in combination with an AI for appropriate patients with HR+/HER2- mBC.1
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Explore data proven across 3 phase III trials
KISQALI + AI in 1L postmenopausal patients
KISQALI + fulvestrant in 1L/2L postmenopausal patients
KISQALI + ET in 1L premenopausal patients
MONALEESA study information
MONALEESA-2 was a randomized, double-blind, placebo-controlled, phase III study of KISQALI + letrozole (n=334) vs placebo + letrozole (n=334) in postmenopausal patients with HR+/HER2- mBC who received no prior therapy for advanced disease. OS was a secondary end point; PFS was the primary end point. At a median follow-up of 80 months, mOS was 63.9 months with KISQALI + letrozole (95% CI: 52.4-71.0) vs 51.4 months with placebo + letrozole (95% CI: 47.2-59.7); HR=0.765 (95% CI: 0.628-0.932); P=0.004.2-4
MONALEESA-3 was a randomized, double-blind, placebo-controlled, phase III study of KISQALI + fulvestrant (n=484) vs placebo + fulvestrant (n=242) in postmenopausal patients with HR+/HER2- mBC who received no or only 1 line of prior ET for advanced disease. OS was a secondary end point; PFS was the primary end point. In an exploratory analysis of a 1L subgroup of patients receiving KISQALI + fulvestrant (n=237) or placebo + fulvestrant (n=128), at a median follow-up of 71 months mOS was 67.6 months with KISQALI + fulvestrant (95% CI: 59.6-NR) vs 51.8 months with placebo + fulvestrant (95% CI: 40.4-61.2); HR=0.673 (95% CI: 0.504-0.899). At a median follow-up of 39 months, statistical significance was established for overall survival in the ITT population; HR=0.724 (95% CI: 0.568-0.924); P=0.00455. Results from the 71-month analysis were not prespecified and were observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error.2,5-7
MONALEESA-7 was a randomized, double-blind, placebo-controlled, phase III study of KISQALI + ET (NSAI or tamoxifen) + goserelin (n=335) vs placebo + ET (NSAI or tamoxifen) + goserelin (n=337) (ITT) in premenopausal patients with HR+/HER2- mBC who received no prior ET for advanced disease. KISQALI is not indicated for concomitant use with tamoxifen. Efficacy results are from a prespecified subgroup analysis of 495 patients who received KISQALI (n=248) or placebo (n=247) with an NSAI + goserelin and were not powered to show statistical significance. OS was a secondary end point; PFS was the primary end point. At a median follow-up of 54 months (exploratory analysis), mOS was 58.7 months with KISQALI + NSAI + goserelin (95% CI: 48.5-NR) vs 47.7 months with placebo + NSAI + goserelin (95% CI: 41.2-55.4); HR=0.798 (95% CI: 0.615-1.035). At a median follow-up of 35 months, statistical significance was established for overall survival in the ITT population; HR=0.71 (95% CI: 0.54-0.95); P=0.00973. Results from the 54-month analysis were not prespecified and were observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error.2,8-11
An expert discusses proven overall survival across 3 phase III trials in patients with HR+/HER2- mBC
“To have now a significant prolongation of overall survival and reaching the...5-year mark in overall survival in breast cancer is amazing.” —Gabriel Hortobagyi, MD
Downloadable resources
Novartis strives to ensure you have everything you need to provide the best care for your patients. Explore our library of resources designed to support you, your staff, and your patients. These tools contain useful information that can help your patients get started and stay on treatment with KISQALI.