Treatment with KISQALI® (ribociclib) in eligible pre- and perimenopausal women with HR+/HER2− aBC

Typically, premenopausal women with aBC face a worse prognosis and more aggressive cancer compared to postmenopausal women^2,3

Efficacy of KISQALI

Explore the efficacy data for KISQALI + ET in pre/perimenopausal patients from the MONALEESA-7 trial.

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MONALEESA 2: mOS at median 80-month follow-up was 63.9 months with KISQALI + AI vs 51.4 months with AI alone (HR=0.76; 95% CI: 0.63–0.93; p=0.008). 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.⁷ 

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: 52.0–63.2) in the KISQALI group and 45.9% (95% CI: 36.9–54.5) in the placebo group, (HR=0.72; 95% CI: 0.57–0.92; p=0.00455).^6,8 

MONALEESA-7: The estimated OS at 42-month follow-up was 70.2% (95% CI: 63.5–76.0) in the KISQALI + ET group (n=335) and 46.0% (95% CI: 32.0–58.9) in the placebo + ET group (HR for death, 0.71; 95% CI: 0.54–0.95; p=0.00973 by log-rank test).⁹

KISQALI is not recommended to be used in combination with tamoxifen.¹

Summary of 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, vomiting, headache, constipation, alopecia, cough, rash, back pain, anaemia and abnormal liver function tests.¹

For more safety information, click here.

Please consult your local Summary of Product Characteristics for the full KISQALI safety and tolerability profile.

Study design

MONALEESA-2: N=668, double-blind, placebo-controlled, 1:1 randomised, multicentre, phase III trial in postmenopausal women with HR+/HER2− aBC. As 1L in advanced disease. No prior ET for aBC and no previous systemic chemotherapy for advanced disease. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg continuous). The primary endpoint was locally assessed PFS, and the key secondary endpoint was OS. Other secondary endpoints included the ORR (complete or partial response), the CBR (overall response plus stable disease lasting 24 weeks or more), safety, and QoL assessments.¹⁰

MONALEESA-3: N=726, double-blind, placebo-controlled, 2:1 randomised, phase III trial. As 1L and 2L in advanced disease plus those with early relapse in postmenopausal women with HR+/HER2– aBC. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + 500 mg intramuscular fulvestrant. 1L defined as: newly diagnosed (de novo) aBC patients or patients with relapse >12 months from completion of (neo)adjuvant ET with no treatment for aBC or metastatic disease. 2L was defined as: relapse on or within 12 months from completion of  (neo)adjuvant ET with no treatment for advanced or metastatic disease (early relapse); relapse >12 months from completion of (neo)adjuvant therapy with subsequent progression after one line of ET for advanced or metastatic disease, and advanced or metastatic breast cancer at diagnosis that progressed after one line of ET for advanced disease with no prior (neo)adjuvant treatment for early disease. The primary endpoint was locally assessed PFS. Secondary endpoints included OS, ORR, CBR, and safety and tolerability.¹¹

MONALEESA-7: N=672, double-blind, placebo-controlled, 1:1 randomised, phase III trial in pre/perimenopausal women with HR+/HER2− aBC. As 1L in advanced disease and in patients who received 1 or fewer lines of chemotherapy for aBC. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + ET (letrozole 2.5 mg or anastrozole 1 mg) or tamoxifen 20 mg orally once daily continuously + LHRH agonist (goserelin 3.6 mg subcutaneously on Day 1 of every cycle). The primary endpoint was investigator-assessed PFS. The key secondary endpoint was OS, defined as the time from randomisation to death from any cause.⁹

KISQALI is not recommended to be used in combination with tamoxifen.¹

1L, first-line; 2L, second-line; aBC, advanced breast cancer; AI, aromatase inhibitor; AR, adverse reaction; CBR, clinical benefit rate; CDK4/6i, cyclin-dependent kinase 4 and 6 inhibitor; CI, confidence interval; 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; mOS, median overall survival; mPFS, median progression-free survival; NR, not reached; NSAI, non-steroidal anti-inflammatory; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; QoL, quality of life.

References

1. KISQALI® (ribociclib) Summary of Product Characteristics.

2. Bardia A & Hurvitz S. Clin Cancer Res 2018;24(21):5206–5218.

3. Azim Jr HA & Partridge AH. Breast Cancer Res 2014;16:427.

4. Lu YS, et al. Clin Cancer Res 2022;28(5):851–859.

5. Tripathy MD, et al. Lancet Oncol 2018;19(7):904–915.

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

7. Hortobagyi GN et al. N Engl J Med 2022;386:942-950.

8. Slamon DJ, et al. N Engl J Med 2020;382(6):514–524.

9. Im SA, et al. N Engl J Med 2019;381(4):307–316.

10. Hortobagyi GN, et al. N Engl J Med 2016;375–1738–1748.

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

UK | February 2025 | 442195