Prescribing information

 

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

 

Kaplan-Meier graph showing progression-free survival with KISQALI or placebo + AI in MONALEESA-2

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

 

Graph showing the change in tumour size from baseline to week 8 with KISQALI or placebo + AI in all patients with measurable disease in MONALEESA-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

Patients (N=668)

  • Postmenopausal women with HR+/HER2− aBC
  • No prior endocrine therapy for aBC
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)

Primary endpoint3:

  • Locally assessed progression-free survival

Secondary endpoints3:

  • Overall response rate
  • Clinical benefit rate
  • Safety
  • 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.

References

  1. KISQALI® (ribociclib) Summary of Product Characteristics.
  2. Janni W, et al. Poster 245PD presented at ESMO Congress 2017, 8–12 September 2017, Madrid, Spain.
  3. Hortobagyi GN, et al. N Engl J Med 2016;375(18):1738–1748.
HCP20-C012 July 2020.
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