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