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