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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:

kisqali-shield-icon-200.jpg

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:

Icon of the letters OS.

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

kisqali-calendar-icon-200.jpg

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.

Kisqali Postmenopausal Sled

Click to learn about the efficacy of KISQALI in premenopausal patients with HR+/HER2– aBC

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Find out more about the safety profile of KISQALI + ET
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Explore the QoL data with KISQALI + ET
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Learn more about ESMO-MCBS and KISQALI + ET
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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

  

1L, first-line; 2L, second-line; aBC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; 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; ORR, overall response rate; OS, overall survival;  QoL, quality of life.

 

References

  1. KISQALI (ribociclib) Summary of Product Characteristics.

  2. Hortobagyi GN, et al. Ann Oncol 2018;29:1541–1547.

  3. Slamon DJ, et al. J Clin Oncol 2018;36(24):2465–2472.

  4. Hortobagyi GN, et al. N Engl J Med 2022;386:942–950.

  5. Neven P, et al. Breast Cancer Res 2023;25:103.

  6. Lu Y-S, et al. Clin Cancer Res 2022;28:851–859.

  7. Jackisch C, et al. Poster presentation P4-01-01. San Antonio Breast Cancer Symposium 2022, 6–10 December, San Antonio, USA.

  8. Harbeck N, et al. Ther adv Med Oncol 2020;12:1–8.

  9. Verma S, et al. Br Cancer Res Treat 2018;170:535–545.

  10. Fasching PA, et al. Breast 2020;54:148–154.

  11. Slamon DJ, et al. N Engl J Med 2020;382:514–524.

  12. Im S-A, et al. N Engl J Med 2019;381(4):307–316.

UK | August 2025 | 442190-1

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.