More life for living
MONALEESA-7: KISQALI + AI in 1L premenopausal patients
OVERALL SURVIVAL
Nearly 5 years median overall survival for 1L premenopausal patients
At a median follow-up of 54 months
Hazard ratio is based on unstratified Cox model.2
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
At a median follow-up of 35 months
Statistical significance was established for OS in the 1L ITT population; P=0.00973 (HR=0.71 [95% CI: 0.54-0.95]).3
In the subgroup of patients who received tamoxifen, an increased risk for QT prolongation was observed. KISQALI is not indicated for concomitant use with tamoxifen4
1L, first line; AI, aromatase inhibitor; HR, hazard ratio; ITT, intent to treat; mOS, median overall survival; NR, not reached; NSAI, nonsteroidal aromatase inhibitor; OS, overall survival.
TIME TO CHEMOTHERAPY
Median time to chemotherapy delayed over 4 years
At a median follow-up of 54 months
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 error3
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.2,8-11
ET, endocrine therapy; 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.
