Prescribing information


Efficacy of KISQALI + fulvestrant in a first-line and second-line postmenopausal patient population.

KISQALI is the only CDK4/6i to show significant OS in two phase III trials1–5

ITT population: OS with KISQALI + fulvestrant or placebo + fulvestrant (N=726)1


Kaplan-Meier graph showing overall survival with KISQALI or placebo + fulvestrant in MONALEESA-3

Adapted from Slamon, et al. 2020.1


The ITT population included postmenopausal patients with HR+/HER2− aBC (N=726) randomised to KISQALI + fulvestrant or placebo + fulvestrant.* The difference in the relative risk of death was statistically significant (p=0.0045).1

In a subgroup analysis of second-line and early-relapse patients (n=346), the OS benefit with KISQALI + fulvestrant vs placebo + fulvestrant was consistent with the ITT population (40.2 months vs 32.5 months; HR=0.73; 95% CI: 0.53–1.00).1

Primary endpoint: PFS in the ITT population

  • mPFS in the ITT population was 20.6 months in the KISQALI + fulvestrant arm vs 12.8 months in the placebo + fulvestrant arm, HR=0.59 (95% CI: 0.49–0.71)1*


Primary endpoint: PFS (investigator-assessed)


Kaplan-Meier graph showing progression-free survival (PFS) with KISQALI or placebo + fulvestrant in MONALEESA-3


  • The hazard ratio of 0.593 corresponds to a 41% reduction in risk of progression in the ribociclib vs placebo arm


MONALEESA-3: a phase III trial in postmenopausal women3,6

MONALEESA-3 was a randomised (2:1), double blind, placebo-controlled, multicentre, phase III trial

Patients (N=726)

  • Postmenopausal women with HR+/HER2− aBC
  • No prior endocrine therapy or after disease progression on 1L endocrine therapy for aBC
KISQALI (600 mg/day; 3 weeks on/1 week off) + fulvestrant (500 mg) (n=484)
Placebo (3 weeks on/1 week off) + fulvestrant (500 mg)(n=242)

Analyses were performed in the following subgroups1:

  • Patients receiving 1L therapy
  • Patients receiving 2L therapy plus those with early relapse (within 12 months after completion of adjuvant or neoadjuvant endocrine therapy)

Primary endpoint6:

  • Locally assessed progression-free survival

Secondary endpoints6:

  • Overall survival
  • Overall response rate
  • Clinical benefit rate
  • Safety and tolerability


*KISQALI + fulvestrant is currently only funded in the second-line setting.

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

1L, first line; 2L, second line; aBC, advanced breast cancer; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; HR, hazard ratio; HR+/HER2−, hormone receptor-positive/human epidermal growth factor 2-negative; ITT, intention to treat; mOS, median overall survival; mPFS, median progression-free survival; NR, not reached; OS, overall survival; PFS, progression-free survival.


  1. Slamon DJ, et al. N Engl J Med 2020;382(6):514–524.
  2. Im S-A, et al. N Engl J Med 2019;381(4):307–316.
  3. KISQALI® (ribociclib) Summary of Product Characteristics.
  4. Hortobagyi GN, et al. Ann Oncol 2018;29(7):1541–1547.
  5. Hurvitz S, et al. LBA1008. Presented at ASCO 2019, 31 May–4 June 2019, Chicago, USA.
  6. Slamon DJ, et al. J Clin Oncol 2018;36(24):2465–2472.
HCP20-C011 July 2020.

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