1. Medicines
  2. Oncology
  3. KISQALI® ▼ (ribociclib)
  4. Efficacy
  5. Study designs

Prescribing information

 

Efficacy – Study designs

Study designs for the three pivotal phase III trials of KISQALI.

MONALEESA-7: a randomised (1:1), double-blind, placebo-controlled, multicentre phase III trial1,2

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.1

Primary endpoint3:

  • Investigator-assessed progression-free survival

Secondary endpoints3:

  • 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

 

MONALEESA-3: a randomised (2:1), double-blind, placebo-controlled, multicentre phase III trial1,4

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 o) + fulvestrant (500 mg) (n=484)
Placebo (3 weeks on/1 week o) + fulvestrant (500 mg)(n=242)

Analyses were performed in the following subgroups5:

  • 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 endpoint4:

  • Locally assessed progression-free survival

Secondary endpoints4:

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

 

MONALEESA-2: a randomised (1:1), double-blind, placebo-controlled, multicentre phase III trial1,6

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 endpoint6:

  •  Locally assessed progression-free survival

Secondary endpoints6:

  • 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.1

1L, first line; 2L, second line; aBC, advanced breast cancer; AI, aromatase inhibitor; ECOG, Eastern Cooperative Oncology Group; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer’s core quality-of-life questionnaire; HR+/HER2−, hormone receptor-positive/human epidermal growth factor 2-negative; LHRH, luteinising hormone-releasing hormone.

References

  1. KISQALI® (ribociclib) Summary of Product Characteristics.
  2. Im S-A, et al. N Engl J Med 2019;381(4):307–316.
  3. Tripathy D, et al. Lancet Oncol 2018;19(7):904–915.
  4. Slamon DJ, et al. J Clin Oncol 2018;36(24):2465–2472.
  5. Slamon DJ, et al. N Engl J Med 2020;382(6):514–524.
  6. Hortobagyi GN, et al. N Engl J Med 2016;375(18):1738–1748.
HCP20-C009 July 2020.
Oncology
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