1. Medicines
  2. Oncology
  3. KISQALI® ▼ (ribociclib)
  4. Efficacy
  5. Premenopausal women

Prescribing information

 

Efficacy – Premenopausal women

Efficacy of KISQALI + non-steroidal aromatase inhibitor (NSAI) in a premenopausal patient population.

KISQALI is the only CDK4/6i to demonstrate significant overall survival (OS) specifically in the premenopausal setting1–3

In a prespecified subgroup analysis, KISQALI + NSAI + LHRH agonist demonstrated significantly increased OS vs placebo + NSAI + LHRH agonist, with a 30% reduction in risk of death.1

Prespecified subgroup analysis: OS with KISQALI + NSAI + LHRH agonist or placebo + NSAI + LHRH agonist (N=495)1

 

Kaplan-Meier graph showing overall survival with KISQALI or placebo + NSAI + LHRH agonist in MONALEESA-7

Adapted from Im, et al. 2019.1

 

The ITT population included all patients (N=672) randomised to KISQALI or placebo with either tamoxifen* or an NSAI, both with goserelin.4

Table showing progression-free survival and overall survival results from MONALEESA-7

*KISQALI is not recommended to be used in combination with tamoxifen.5

MONALEESA-7: a phase III trial in premenopausal women1,5

MONALEESA-7 was a randomised (1:1), double-blind, placebo-controlled, multicentre, phase III trial

Patients (N=672)

  • Pre/perimenopausal women with HR+/HER2− aBC
  • No prior endocrine therapy for aBC
  • ≤1 line of chemotherapy for aBC
 KISQALI (600 mg/day; 3 weeks on/1 week off) + AI (letrozole 2.5 mg or anastrozole 1 mg) or tamoxifen* (20 mg) orally + LHRH agonist (3.6 mg) (n=335)
Placebo (3 weeks on/1 week off) + AI (letrozole 2.5 mg or anastrozole 1 mg) or tamoxifen* (20 mg) orally + LHRH agonist (3.6 mg) (n=337)

*KISQALI is not recommended to be used in combination with tamoxifen.5

Primary endpoint4:

  • Investigator-assessed progression-free survival

Secondary endpoints4:

  • Overall survival (key secondary endpoint)
  • Proportion of patients who achieved an objective response
  • Proportion of patients who achieved clinical benefit
  • Time to response
  • Duration of response
  • Time to definitive deterioration of ECOG performance status from baseline
  • Time to 10% deterioration of EORTC QLQ-C30
  • Safety

 

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.5

aBC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer’s core quality-of-life questionnaire; HR, hazard ratio; HR+/HER2−, hormone receptor-positive/human epidermal growth factor 2-negative; ITT, intention to treat; LHRH, luteinising hormone-releasing hormone; mOS, median overall survival; NR, not reached; NSAI, non-steroidal aromatase inhibitor; OS, overall survival.

References

  1. Im S-A, et al. N Engl J Med 2019;381(4):307–316.
  2. Finn RS, et al. N Engl J Med 2016;375(20):1925–1936.
  3. Goetz MP, et al. J Clin Oncol 2017;35(32):3638–3646.
  4. Tripathy D, et al. Lancet Oncol 2018;19(7):904–915.
  5. KISQALI® (ribociclib) Summary of Product Characteristics.
HCP20-C010 July 2020.
Oncology
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