Efficacy of KISQALI + letrozole in a first-line postmenopausal patient population.
KISQALI + letrozole is proven to deliver efficacy in the first-line setting with an AI1
KISQALI + letrozole demonstrated a statistically significant improvement in PFS vs placebo + letrozole, with a 43% reduction in risk of disease progression.1
MONALEESA-2: Investigator-assessed PFS with KISQALI + letrozole vs placebo + letrozole in postmenopausal patients (Data cutoff 02 January 2017)1
Adapted from KISQALI Summary of Product Characteristics.1
MONALEESA-2: N=668, double-blind, placebo-controlled, 1:1 randomisation, multicentre, phase III trial in postmenopausal women with HR+/HER2− aBC. As 1L in advanced disease. No prior endocrine therapy for aBC and no previous systemic chemotherapy for advanced disease. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg continuous).2 The primary endpoint was locally assessed progression-free survival and the key secondary endpoint was overall survival. Other secondary endpoints included the overall response rate (complete or partial response), the clinical benefit rate (overall response plus stable disease lasting 24 weeks or more), safety, and quality-of-life assessments.2
KISQALI demonstrated tumour shrinkage as early as 8 weeks3
In MONALEESA-2, 76% of patients treated with KISQALI + letrozole saw their tumours shrink at week 8 vs 67% with placebo + letrozole.3
MONALEESA-2: Change in tumour size from baseline in all patients with measurable disease at the first post-baseline evaluation (Week 8)3
Adapted from Janni W, et al. 2018.3
Results reported at 8 weeks were not prespecified and are observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error
KISQALI is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.1
1L, first line; aBC, advanced breast cancer; AI, aromatase inhibitor; CI, confidence interval; HR, hazard ratio; HR+/HER2−, hormone receptor-positive/human epidermal growth factor 2-negative; mPFS, median progression-free survival; PFS, progression-free survival.
- KISQALI (ribociclib). Summary of Product Characteristics.
- Hortobagyi GN, et al. N Engl J Med. 2016;375(18):1738–1748.
- Janni W, et al. Breast Cancer Res Treat. 2018;169:469–479.