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