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Efficacy of KISQALI® (ribociclib) in eBC
Indication:1
KISQALI, in combination with an aromatase inhibitor (AI), is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) at high risk of recurrence (see section 5.1 of the SmPC for selection criteria).
In pre- or perimenopausal women, or in men, the AI should be combined with a luteinising hormone-releasing hormone (LHRH) agonist
KISQALI is not recommended to be used in combination with tamoxifen.
For more information on the safety profile in eBC, click here.
Please consult your local Summary of Product Characteristics (SmPC) for the full KISQALI safety and tolerability profile.
The NATALEE trial included a wide range of patients with HR+/HER2− eBC*2,3
The multicentre, randomised, open-label NATALEE trial enrolled a range of patients, including those with high-risk N0 disease.3
NATALEE study design:3,4
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In a pre-specified analysis of HR+/HER2– eBC patients, KISQALI + NSAI was observed to reduce the risk of invasive disease, recurrence or death over 5 years vs NSAI alone2
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Adapted from Crown JP, et al. 20252 and Hortobagyi GN, et al. 2025.4
The results above are those of an exploratory analysis (cutoff: 28 May 2025) and should not be regarded as statistically significant.2 The primary endpoint of the study was met at the primary analysis (11 January 2023 cut-off). A statistically significant improvement in iDFS (HR=0.748, 95% CI: 0.618–0.906; one-sided stratified log-rank test p=0.0014) was demonstrated in patients receiving Kisqali plus AI over AI alone.3
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At 5 years KISQALI showed a consistent iDFS benefit across the broadest range of CDK4/6i-eligible patients, including high-risk N0,∥ regardless of nodal status, stage or menopausal status.1–3
Summary of the safety profile
The most common ADRs (reported at a frequency ≥20%) in the dataset for which the frequency for KISQALI + AI exceeds the frequency for AI alone were neutropenia, infections, nausea, headache, fatigue, leukopenia and abnormal liver function tests. The most common grade 3/4 ADRs (reported at a frequency of ≥2%) in the dataset for which the frequency for KISQALI + AI exceeds the frequency for AI alone were neutropenia, abnormal liver function tests and leukopenia.1
NATALEE: The most common adverse events (AEs) of any grade were neutropenia (62.5% with KISQALI + NSAI vs 4.6% with NSAI alone), arthralgia (37.3% vs 43.3%, respectively), and nausea (23.3% vs 7.8%, respectively). The most common grade ≥3 event was neutropenia (44.3% with KISQALI + NSAI vs 0.9% with NSAI alone). Grade ≥3 liver-related AEs occurred in 8.6% of patients in the KISQALI + NSAI arm and 1.7% in the NSAI-alone arm.4
Learn about the safety profile of KISQALI in eBC
Learn about the efficacy of KISQALI in aBC
*Key inclusion criteria: Patients in NATALEE were diagnosed up to 18 months prior to randomisation with HR+/HER2− eBC. Randomisation was stratified by menopausal status, anatomic stage II or III, prior (neo)adjuvant CT and geographic region. Permitted to have already received any standard (neo)adjuvant ET, but must be randomised within 12 months of the initial start date of ET. Key exclusion criteria: distant metastases of BC beyond the regional lymph nodes and/or evidence of disease after curative surgery; prior treatment with CDK4/6i; prior treatment with anthracyclines at cumulative doses of ≥450 mg/m2 for doxorubicin or ≥900 mg/m2 for epirubicin; major surgery, CT or radiotherapy within 14 days prior to randomisation; prior treatment with tamoxifen, raloxifene or AIs for reduction in risk of BC and/or prior treatment for osteoporosis in the preceding 2 years.3
†Anatomic stage IIA inclusive of N0 (with grade 2 and evidence of high risk: Ki-67 ≥20%, Oncotype DX Breast Recurrence Score ≥26, or high risk via genomic risk profiling) or grade 3 and N1, and anatomic stage IIB inclusive of N0 or N1. Enrollment of patients with stage II capped at 40%.3
‡Anatomic stage III inclusive of N0, N1, N2, or N3.3
§Men and premenopausal women also received goserelin.3
∥High-risk N0: all T3–4N0 patients, T2N0 grade 2 patients with additional risk factors, such as Ki-67 score ≥20%, genomic risk defined as an Oncotype DX Breast Recurrence Score of ≥26, or Prosigna/PAM50, MammaPrint, or EndoPredict EPclin high-risk scores, or T2N0 grade 3 patients.2
aBC, advanced breast cancer; ADR, adverse drug reaction; AI, aromatase inhibitor; ARR, absolute risk reduction; BC, breast cancer; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CT, chemotherapy; CI, confidence interval; DDFS, distant disease-free survival; eBC, early breast cancer; ER, oestrogen receptor; ET, endocrine therapy; G, grade; HER2−, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; HRQoL, health-related quality of life; iDFS, invasive disease-free survival; LHRH, luteinising hormone-releasing hormone; N0, no nodal involvement; N1, 1–3 axillary lymph nodes; N2, 4–9 axillary lymph nodes; N3, ≥10 axillary lymph nodes or collarbone lymph nodes; NSAI, non-steroidal aromatase inhibitor; OS, overall survival; R, randomisation; SoC, standard of care; STEEP, standardised definitions for efficacy endpoints; T, tumour; T2, tumour is more than 2 cm but less than 5 cm; T3, tumour is more than 5 cm; T4, tumour of any size growing into the chest wall or skin, includes inflammatory breast cancer.
References
KISQALI® (ribociclib) Summary of Product Characteristics. Available at www.medicines.ie.
Crown JP, et al. ESMO Open 2025;10(11):105858.
Slamon DJ, et al. Ther Adv Med Oncol 2023;15:17588359231178125.
Hortobagyi GN, et al. Ann Oncol 2025;36(2):149–157.
IE11637362 | May 2026
