Treatment with KISQALI® (ribociclib) in eligible postmenopausal women with HR+/HER2– aBC
Indications:1
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
KISQALI is not recommended to be used in combination with tamoxifen.
PFS benefit:
In MONALEESA-2, KISQALI + AI demonstrated a statistically significant mPFS benefit of 9.3 months vs placebo + AI2
At median follow-up of 26.4 months, mPFS was 25.3 months (95% CI: 23.0–30.3) for KISQALI + AI and 16.0 months (95% CI: 13.4–18.2) for placebo +AI (HR=0.57; 95% CI: 0.46–0.70, log-rank p=9.63x10-8)2
In MONALEESA-3, KISQALI + fulvestrant demonstrated a statistically significant mPFS benefit of 7.7 months versus placebo + fulvestrant3
At median follow-up of 20 months, mPFS was 20.5 months (95% CI: 18.5–23.5) for KISQALI + fulvestrant and 12.8 months (95% CI: 10.9–16.3) for placebo + fulvestrant (HR=0.59; 95% CI: 0.48–0.73, p<0.001)3
OS benefit:
1L KISQALI + AI increased mOS by >1 year (12.5 months) vs placebo + AI in postmenopausal patients4
MONALEESA-2 secondary endpoint: At median follow-up of 80 months, mOS was 63.9 months (95% CI: 52.4–71.0) for KISQALI + AI and 51.4 months (95% CI: 47.2–59.7) for placebo + AI (HR=0.76; 95% CI: 0.63–0.93, two-sided p=0.008)4
In an exploratory analysis, 1L KISQALI + fulvestrant was observed to demonstrate significant OS vs fulvestrant + placebo in postmenopausal patients5
This was an exploratory OS analysis with an extended median follow-up of 71 months.5
Postmenopausal patients with HR+/HER2– aBC were randomised 2:1 to 1L/2L KISQALI + fulvestrant or placebo + fulvestrant. mOS at median 70.8-month follow-up was 67.6 months with 1L KISQALI + fulvestrant vs 51.8 months with fulvestrant alone (HR=0.67; 95% CI: 0.50–0.90)5
See below for MONALEESA-2 and MONALEESA-3 study designs
Efficacy of KISQALI
Explore efficacy data for KISQALI + AI and KISQALI + fulvestrant in postmenopausal patients from the MONALEESA-2 and MONALEESA-3 trials.
Click the start button to open the interactive detail aid in a new window
Click to learn about the efficacy of KISQALI in premenopausal patients with HR+/HER2– aBC
In HR+/HER2– aBC, KISQALI + ET was the only CDK4/6i with significant 1L OS benefit across three Phase III trials*†4–6
An established safety profile with KISQALI + ET1,7
In an exploratory analysis, KISQALI + ET preserved QoL (EORTIC or TTD) across all three Phase III trials vs placebo + ET*‡8–10
Patient reported outcomes for health-related QoL were secondary endpoints8–10
KISQALI received an ESMO-MCBS score of 5/5 when used in combination with LHRH and with ET§11
KISQALI is not recommended to be used in combination with tamoxifen.1
Summary of the safety profile
The most common adverse reactions (ARs) (reported at a frequency ≥20%) in the pooled dataset for which the frequency for KISQALI plus any combination exceeds the frequency for placebo plus any combination were neutropenia, infections, nausea, fatigue, diarrhoea, leukopenia, vomitting, headache, constipation, alopecia, cough, rash, back pain, anaemia and abnormal liver function tests.1
For more safety information, click here.
For the full safety profile, please refer to the KISQALI Summary of Product Characteristics.
Study designs
MONALEESA-2: Phase III trial of KISQALI + AI (n=334) vs placebo + AI (n=334) in postmenopausal patients with HR+/HER2– aBC. The primary endpoint was locally assessed PFS. The key secondary endpoint was OS. Other secondary endpoints included ORR and safety.2
MONALEESA-3: Phase III trial of KISQALI + fulvestrant (n=484) vs placebo + fulvestrant (n=242) in postmenopausal patients with HR+/HER2– aBC who were treatment naive or had received up to 1 line of prior ET in the advanced setting. The primary endpoint was locally assessed PFS. Secondary endpoints included OS, ORR and safety.3
*ET is defined as AI or fulvestrant and LHRH.
†MONALEESA-2: At 60-month follow-up, the Kaplan–Meier estimate of OS was 52.3% (95% CI: 46.5–57.7) in the KISQALI + AI group and 43.9% (95% CI: 38.3–49.4) in the placebo group; at 72-month follow-up, it was 44.2% (95% CI: 38.5 to 49.8) and 32.0% (95% CI: 26.8 to 37.3), respectively. Analysis showed a significant and clinically meaningful increase in OS of 12.5 months with 1L KISQALI + AI vs placebo + AI in postmenopausal patients with HR+/HER2– aBC.4 MONALEESA-3: KISQALI + fulvestrant showed a significant OS benefit over placebo + fulvestrant. The estimated OS at 42-month follow-up was 57.8% (95% CI: 52.0 to 63.2) in the KISQALI group and 45.9% (95% CI: 36.9 to 54.5) in the placebo group, (HR=0.72; 95% CI: 0.57 to 0.92; p=0.00455).5,12 MONALEESA-7: The estimated OS at 42-month follow-up was 70.2% (95% CI: 63.5 to 76.0) in the KISQALI + ET group and 46.0% (95% CI: 32.0 to 58.9) in the placebo + ET group (HR for death=0.71, 0.71; 95% CI: 0.54 to 0.95; p=0.00973 by log-rank test).6,13
‡QoL was assessed using the EORTC QLQ-C30 questionnaire: a validated tool used worldwide to assess QoL in patients with cancer. Time to definitive deterioration 10% (TTD; defined as ≥10% worsening of the scales score relative to baseline, with no later improvement above this threshold observed during the treatmaent period, or death due to any cause) in the global health status/QOL score was investigated.8,9 MONALEESA-2: KISQALI + AI maintained QoL (mTTD ≥10%) for 27.7 months vs 27.6 months with placebo + AI (HR 0.944;95% CI: 0.720–1.237).9 MONALEESA-3: KISQALI + fulvestrant maintained QoL (mTTD ≥10%) for 35.9 months vs 33.1 months with placebo +fulvestrant alone (HR 0.81; 95% CI: 0.62–1.06).10 MONALEESA-7: KISQALI + ET maintained QoL (mTTD ≥10%) for 35.8 months vs 23.3 months with placebo + ET (HR 0.67; 95% CI: 0.52–0.86).9
§ESMO-MCBS scorecards in HR+/HER2– aBC demonstrated that KISQALI has a proven OS benefit in combination with ET and is the only CDK4/6i to demonstrate proven OS benefit in combination with ET. Other CDK4/6is have demonstrated OS benefit in combination with fulvestrant.11
1L, first-line; 2L, second-line; aBC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; EORTC QLQ-C30, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire; ESMO-MCBS, European Society for Medical Oncology Magnitude of Clinical Benefit Scale; ET, endocrine therapy; HER2−, human epidermal growth factor receptor-2 negative; HR, hazard ratio; HR+, hormone receptor-positive; LHRH, luteinising hormone-releasing hormone; mPFS, median progression free survival; mOS, median overall survival; mTTD, median time to deterioration; ORR, overall response rate; OS, overall survival; QoL, quality of life; TTD, time to deterioration.
References
KISQALI (ribociclib) Summary of Product Characteristics.
Hortobagyi GN, et al. Ann Oncol 2018;29:1541–1547.
Slamon DJ, et al. J Clin Oncol 2018;36(24):2465–2472.
Hortobagyi GN, et al. N Engl J Med 2022;386:942–950.
Neven P, et al. Breast Cancer Res 2023;25:103.
Lu Y-S, et al. Clin Cancer Res 2022;28:851–859.
Jackisch C, et al. Poster presentation P4-01-01. San Antonio Breast Cancer Symposium 2022, 6–10 December, San Antonio, USA.
Harbeck N, et al. Ther adv Med Oncol 2020;12:1–8.
Verma S, et al. Br Cancer Res Treat 2018;170:535–545.
Fasching PA, et al. Breast 2020;54:148–154.
European Society for Medical Oncology. Breast cancer. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards?mcbs_score_cards_form%5BsearchText%5D=&mcbs_score_cards_form%5Btumourtype%5D=0&mcbs_score_cards_form%5Btumour-sub-type%5D=Breast+Cancer [Accessed February 2025].
Slamon DJ, et al. N Engl J Med 2020;382:514–524.
Im S-A, et al. N Engl J Med 2019;381(4):307–316.
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.