Can KISQALI help patients with HR+, HER2- metastatic breast cancer live longer?
KISQALI® (ribociclib), in combination with an aromatase inhibitor (AI) or fulvestrant, demonstrated a statistically significant overall survival (OS) benefit across 3 phase III MONALEESA clinical trials. These trials included a broad range of premenopausal and postmenopausal patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2–) metastatic breast cancer (mBC). Review overall survival data from the MONALEESA-2, MONALEESA-3, and MONALEESA-7 trials below.1-5
NCCN GUIDELINES®
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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.6
1L, first line; AI, aromatase inhibitor; CDK, cyclin-dependent kinase; HER2-, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; mBC, metastatic breast cancer.
OS RESULTS
KISQALI is the only CDK4/6 inhibitor to achieve statistically significant OS in a broad range of patients across 3 phase III trials
1L refers to patients with mBC across all trials.
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=0.004.1,2
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.1,3,7,8
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.1,4,5,9,10
Across the 3 phase III MONALEESA trials, the outcome was the same, regardless of:
- Menopausal status
- Age (≥18 years)
- Use of AI or fulvestrant
What overall survival results were observed across the MONALEESA trials in HR+/HER2- mBC?
KISQALI was proven across 3 phase III trials to help patients with HR+/HER2- mBC live longer, regardless of menopausal status. Review the overall survival data from MONALEESA-2, MONALEESA-3, and MONALEESA-7.
Swipe to explore the MONALEESA trials →
KISQALI + AI in 1L postmenopausal patients
KISQALI + fulvestrant in 1L/2L postmenopausal patients
KISQALI + AI in 1L premenopausal patients
Outcomes in Patients With Aggressive Disease and Visceral Metastases
KISQALI + ET was assessed in 1L patients with visceral metastases in an exploratory, pooled subgroup analysis of the 3 phase III MONALEESA trials, and was evaluated against combination chemotherapy in the phase II RIGHT Choice trial for patients with aggressive disease.
Efficacy Data Across Age Groups, Including Elderly Patients
An exploratory, pooled, post hoc analysis of the MONALEESA-2, MONALEESA-3, and MONALEESA-7 trials evaluated overall survival in patients across different age groups, including elderly patients with HR+/HER2- metastatic breast cancer.
PEER PERSPECTIVE
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.