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Efficacy

KISQALI + AI in premenopausal patients

1L in premenopausal patients: KISQALI the first and only CDK4/6i to achieve 5-year mOS. (1)

MONALEESA-7: mOS at median 54-month follow-up: *(1)

Bar chart illustrating median overall survival (mOS) results from the MONALEESA-7 trial in pre/perimenopausal patients with HR+/HER2– advanced breast cancer at a median follow-up of 54 months. KISQALI + aromatase inhibitor achieved a median OS of 58.7 months versus 47.7 months with aromatase inhibitor alone.
58.7 months †
KISQALI + AI
47.7 months
AI alone

*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. (1,2)
† HR 0.80; 95% CI: 0.62–1.04. (1)

MONALEESA-7 study design

Portrait of a smiling asian premenopausal woman used for MONALEESA-7 breast cancer study design.

MONALEESA-7: N=672, double-blind, placebo-controlled, 1:1 randomised, phase III trial in pre- or perimenopausal women with HR+/HER2− ABC. As 1L in advanced disease and in patients who received 1 or fewer lines of chemotherapy for ABC. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg or anastrozole 1 mg) or tamoxifen* 20 mg orally once daily continuously + LHRH agonist (goserelin 3.6 mg subcutaneously on Day 1 of every cycle).

The primary endpoint was investigatorassessed PFS. The key secondary endpoint was OS, defined as the time from randomisation to death from any cause. (1) * KISQALI should not be co-administered with tamoxifen. (3)