Efficacy of KISQALI + AI in a first-line postmenopausal patient population.
KISQALI + AI is proven to deliver efficacy in the first-line setting with an AI1
KISQALI + AI demonstrated a statistically significant improvement in PFS vs placebo + AI, with a 43% reduction in risk of disease progression.1
PFS per investigator assessment1
Adapted from KISQALI Summary of Product Characteristics.1
KISQALI demonstrated tumour shrinkage as early as 8 weeks2
In MONALEESA-2, 75% of patients treated with KISQALI + AI saw their tumours shrink at week 8 vs 67% with placebo + AI.2
Change in tumour size from baseline in all patients with measurable disease at the first post-baseline evaluation (week 8)2
Adapted from Janni, et al. 2017.2
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.
MONALEESA-2: a phase III trial in postmenopausal women1,3
|MONALEESA-2 was a randomised (1:1), double-blind, placebo-controlled, multicentre, phase III trial|
|KISQALI (600 mg/day; 3 weeks on/1 week off) + AI (letrozole 2.5 mg continuous) (n=334)|
|Placebo (3 weeks on/1 week off) + AI (letrozole 2.5 mg continuous) (n=334)|
- Locally assessed progression-free survival
- Overall response rate
- Clinical benefit rate
- Quality of life assessments
Indication: 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.3
aBC, advanced breast cancer; AI, aromatase inhibitor; 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.
- Janni W, et al. Poster 245PD presented at ESMO Congress 2017, 8–12 September 2017, Madrid, Spain.
- Hortobagyi GN, et al. N Engl J Med 2016;375(18):1738–1748.