KISQALI + AI or fulvestrant is proven to help patients with HR+/HER2- mBC live longer—and that means more time doing what they love
In the MONALEESA-2 trial, 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=0.004.1
National Comprehensive Cancer Network® (NCCN®) differentiates ribociclib (KISQALI®) as the only Category 1 Preferred 1L treatment option in combination with an aromatase inhibitor (AI) for appropriate patients with HR+/HER2- metastatic breast cancer (mBC).2
NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.2
Category 1: Based upon high-level evidence (≥1 randomized phase III trials or high-quality, robust meta-analyses), there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.2
1L, first line; AI, aromatase inhibitor; CDK, cyclin-dependent kinase; HER2-, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; mBC, metastatic breast cancer; mOS, median overall survival.
What overall survival results were observed across the MONALEESA trials in HR+/HER2- mBC?
KISQALI was proven across 3 phase III trials to help premenopausal and postmenopausal patients with HR+/HER2- mBC live longer. Review the overall survival data from MONALEESA-2, MONALEESA-3, and MONALEESA-7.
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KISQALI + AI in 1L postmenopausal patients
KISQALI + fulvestrant in 1L/2L postmenopausal patients
KISQALI + AI 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=0.004.1,3
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. Statistical significance was established for the ITT population in the prespecified OS analysis at a median follow-up of 39 months: mOS was not reached with KISQALI + fulvestrant (95% CI: 42.5-NR) vs 40 months with placebo + fulvestrant (95% CI: 37.0-NR); HR=0.724 (95% CI: 0.568-0.924); P=0.00455. In exploratory analyses of the 1L subgroup of patients receiving KISQALI + fulvestrant (n=237) or placebo + fulvestrant (n=128): At a median follow-up of 39 months, mOS was not reached with KISQALI + fulvestrant vs 45.1 months with placebo + fulvestrant; HR=0.70 (95% CI: 0.48-1.02); 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). Results from the exploratory analyses were not prespecified and were observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error.1,4-6
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. OS was a secondary end point; PFS was the primary end point. In the prespecified OS analysis at a median follow-up of 35 months, mOS was not reached with KISQALI + NSAI + goserelin (95% CI: NR-NR) vs 40.7 months with placebo + NSAI + goserelin (95% CI: 37.4-NR); HR=0.699 (95% CI: 0.501-0.976). Statistical significance was established for overall survival in the ITT population; HR=0.71 (95% CI: 0.54-0.95); P=0.00973. 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). 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.1,7-10
2L, second line; ET, endocrine therapy; ITT, intent to treat; NR, not reached; NSAI, nonsteroidal aromatase inhibitor; OS, overall survival; PFS, progression-free survival.
Jules Cohen, MD, shares his perspective on the proven efficacy of KISQALI
How do overall survival data drive Dr Cohen's treatment decisions in HR+/HER2- mBC? Watch to learn more about how this data is used to make a difference in his practice.
Dr Cohen has been compensated for his time by Novartis Pharmaceuticals Corporation.
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