Can KISQALI + AI help postmenopausal patients with metastatic breast cancer live longer?
KISQALI® (ribociclib), in combination with an aromatase inhibitor (AI), demonstrated a statistically significant overall survival (OS) benefit in first-line (1L) postmenopausal patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) in the phase III MONALEESA-2 trial (median follow-up of 80 months; HR=0.765 [95% CI: 0.628-0.932]; P=0.004). KISQALI is the only cyclin-dependent kinase 4/6 (CDK4/6) inhibitor to achieve statistically significant OS in 1L postmenopausal patients, in combination with an aromatase inhibitor. Review OS data from MONALEESA-2 below.1,2
MONALEESA-2: KISQALI + AI in 1L postmenopausal patients
OVERALL SURVIVAL
Median overall survival exceeded 5 years with KISQALI + AI in 1L postmenopausal patients—which meant MORE life for living
At a median follow-up of 80 months
Hazard ratio is based on stratified Cox model.2
OS benefit with KISQALI increased over time
At 6 years, the survival rate of patients receiving KISQALI + letrozole was 44% vs 32% with placebo + letrozole2
1L, first line; AI, aromatase inhibitor; HR, hazard ratio; mOS, median overall survival; OS, overall survival.
MONALEESA-2: KISQALI + AI in 1L postmenopausal patients
TIME TO CHEMOTHERAPY
Median time to chemotherapy delayed over 4 years in 1L postmenopausal patients
At a median follow-up of 80 months (exploratory analysis)
Time to chemotherapy was evaluated in a post hoc exploratory analysis and was defined as the time from randomization to the beginning of the first chemotherapy after discontinuing study treatment. There was no prespecified statistical procedure controlling for type 1 error
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.1,2
HER2-, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; mBC, metastatic breast cancer; mTTC, median time to chemotherapy; PFS, progression-free survival.