Indications:1,2
- KISQALI® (ribociclib) 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
KISQALI is not recommended to be used in combination with tamoxifen.
For a woman diagnosed with advanced breast cancer (aBC), time matters.
KISQALI + AI is the only CDK4/6i to have demonstrated a statistically significant mOS benefit of 1 year vs placebo + AI in 1L HR+/HER2– aBC postmenopausal patients (secondary endpoint)3,4
In a pooled analysis of the three MONALEESA trials, KISQALI + ET† maintained QoL in the global health score (TTD of EORTC-QLQ C30 scores ≥10% from baseline) relative to placebo + ET in HR+/HER2– aBC patients regardless of menopausal status (secondary endpoint)‡5
KISQALI + ET† is the only CDK4/6i that demonstrated statistically significant OS benefit vs placebo across three Phase III trials in HR+/HER2– aBC patients (secondary endpoint)§3,4,6–9
KISQALI + AI has the highest clinical ESMO-MCBS rating of any CDK4/6i + AI used in 1L postmenopausal patients with HR+/HER2– aBCǁ10
In the three MONALEESA studies, OS and QoL were secondary endpoints
SAFETY PROFILE
KISQALI has a generally manageable safety profile, regardless of patient menopausal status3,4,6–9,11–13
*KISQALI + AI provides a statistically significant PFS benefit of 9.3 months vs placebo + AI (25.3 vs 16 months) and a mOS benefit of 12.5 months vs placebo + AI (63.9 vs 51.4 months) for 1L postmenopausal HR+/HER2– aBC patients (HR=0.76; p=0.004).3,4
†KISQALI is not recommended to be used in combination with tamoxifen.1,2
‡Median TTD ≥10% in global HRQoL in KISQALI + ET† was 39.6 months vs 33.1 months in placebo + ET (HR=0.79; 95% CI: 0.66, 0.94).5
§MONALEESA-2 primary endpoint: PFS. mPFS was 25.3 months in the KISQALI + AI arm vs 16.0 months in the placebo + AI arm, HR 0.57 (95% CI: 0.46–0.70), p<0.0001. Key secondary endpoint: OS. mOS was 63.9 months with KISQALI + AI vs 51.4 months with placebo + AI; HR 0.76 (95% CI: 0.63–0.93), two-sided p=0.008.4 MONALEESA 7 primary endpoint: PFS. mPFS was 23.8 months (95% CI: 19.2–NR) in the KISQALI group versus 13.0 months (95% CI: 11.0–16.4) in the placebo group (HR 0.55, 95% CI: 0.44–0.69; p<0.001). Key secondary endpoint: OS. In the ITT population KISQALI + ET† (not estimated) demonstrated significant OS vs placebo + ET (40.9 months) (HR: 0.71, 95% CI: 0.54–0.95; p=0.00973). Extended follow-up exploratory analysis: An exploratory OS analysis was conducted at a median follow-up of 53.5 months, whereupon OS was 58.7 months with KISQALI + ET† vs 48 months with placebo + ET† ; HR 0.76 (95% CI: 0.61–0.96).6,7,11 MONALEESA-3 primary endpoint: PFS. PFS was 20.5 months in the KISQALI + fulvestrant arm vs 12.8 months in the placebo + fulvestrant arm, HR 0.59 (95% CI: 0.48–0.73), p<0.001. Key secondary endpoint: OS. KISQALI + fulvestrant vs placebo + fulvestrant (p=0.00455), with a median OS of NR vs 40.0 months (95% CI: 37.0–not estimated). Exploratory analysis: mOS 53.7 months (95% CI: 46.9–NR) with KISQALI + fulvestrant vs 41.5 months (95% CI: 37.4–49) with placebo + fulvestrant; HR 0.73 (95% CI: 0.59–0.90).8,9,14
ǁKISQALI holds a rating of 4/5 as a treatment for first-line postmenopausal patients in combination with AI, abemaciclib and palbociclcib have a rating of 3/5.10
1L, first-line; aBC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; EORTC-QLQ C30, European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire; ESMO-MCBS, European Society for Medical Oncology magnitude of clinical benefit scale; ET, endocrine therapy; HER2–, human epidermal growth receptor 2 negative; HR+, hormone receptor-positive; HR, hazard ratio; LHRH, luteinising hormone-releasing hormone; mOS, median overall survival; mTTD, median time-to-deterioration; PFS, progression-free survival; QoL, quality of life; TTD, time-to-deterioration.
References
- KISQALI® (ribociclib) Great Britain Summary of Product Characteristics.
- KISQALI® (ribociclib) Northern Ireland Summary of Product Characteristics.
- Hortobagyi GN, et al. Oral presentation. ESMO Congress 2021, 16–21 September 2021, virtual.
- Hortobagyi GN, et al. N Engl J Med 2022;386(10):942–950 and supplementary data.
- Fasching PA, et al. Oral presentation. European Society for Medical Oncology Breast Cancer Congress; 5–8 May 2021, virtual.
- 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.
- European Society for Medical Oncology. ESMO-MCBS Score cards for HR+/HER2– breast cancer. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/es... [Accessed February 2024].
- Lu Y-S, et al. Clin Cancer Res 2022;2(5):851–859.
- Hortobagyi GN, et al. N Engl J Med 2016;375(18):1738–1748.
- Tripathy D, et al. Poster 166P. European Society for Medical Oncology. 2–4 May 2019, Berlin, Germany.
- Slamon DJ, et al. Ann Oncol 2021;32(8):1015–1024.
