Invasive disease-free survival

Improve iDFS

Help protect patients from recurrence with the Powerful Consistency of KISQALI *⁽¹⁾

Add KISQALI to AI to help prevent >1 in 4 recurrences at 4 years vs AI alone. Now that is GOOD NEWS. ⁽²⁾
Rate of invasive disease-free survival over 3 years. ⁽²⁾

Graph showing 3-year invasive disease-free survival (iDFS) rates from the NATALEE Phase III trial: KISQALI plus NSAI shows a 25% risk reduction vs NSAI alone, with 90.7% iDFS rate vs 87.6% for NSAI alone (ARR = 3.1%, HR 0.749, p = 0.0006)

25%

risk reduction over 3 years

ARR = 3.1%

Adapted from Hortobagyi GN, et al., 2025.

Taking KISQALI for 3 years aims to reduce early and late recurrence by prolonging cell-cycle arrest and driving tumour cells into senescence/death, even after patients are off KISQALI treatment. ^(1,3)
Longer duration to extend time-on-target exposure and may prevent early and late recurrences. ^(1,3)

* vs AI in the NATALEE study and ET in the MONALEESA studies. Consistent results across a broad range of HR+/HER2– eligible patients with statistically significant improvements in iDFS (EBC), PFS and OS (ABC). ⁽¹⁾

Abbreviations

ABC, advanced breast cancer; AI, aromatase inhibitor; ARR, absolute risk reduction; CI, confidence interval; EBC, early breast cancer; ET, endocrine therapy; HER2–, human epidermal growth factor receptor 2 negative; HR, hazard ratio; HR+, hormone receptor positive; iDFS, invasive disease-free survival; OS, overall survival; PFS, progression-free survival.

References

KISQALI (ribociclib). Summary of Product Characteristics.
Fasching PA, et al. Oral LBA13. Presented at the European Society for Medical Oncology Congress 2024, 13–17 September, Barcelona, Spain.
Hortobagyi GN, et al. Ann Oncol. 2025;36(2):149–157.

Reduced risk in all subgroups

Offer KISQALI to all N+ and high risk N0 patients who have received (neo)adjuvant ET for ≤1 year ^(1-4)

This reduced risk of recurrence can benefit a broad range of your eligible patients with HR+/HER2– EBC. ⁽⁵⁾
Invasive disease-free survival risk by patient subgroup. ⁽⁵⁾

Forest plot from the NATALEE Phase III trial showing hazard ratios for invasive disease-free survival (iDFS) with KISQALI plus NSAI versus NSAI alone across patient subgroups: menopausal status, AJCC stage II/III, prior chemotherapy, histological grade, Ki-67 status, nodal status, and prior endocrine therapy.

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Adapted from Hortobagyi GN, et al., 2025.

* Included men and premenopausal women. ⁽⁵⁾
^† From archival tumour tissue. ⁽⁵⁾
^‡ Nodal status classification according to AJCC staging. ⁽⁵⁾
^§ It is important to note that for iDFS subgroup analysis, nodal status was analysed as the worst stage derived per surgical specimen or at diagnosis. ⁽⁵⁾ The values reported in the baseline characteristics were at diagnosis, so this is based on radiological evidence. Therefore, patient numbers for these subgroups may be different from those reported at diagnosis.

Abbreviations

AI, aromatase inhibitor; AJCC, American Joint Committee on Cancer; CI, confidence interval; CT, chemotherapy; eBC, early breast cancer; ET, endocrine therapy; HR, hazard ratio; iDFS, invasive disease-free survival; 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.

References

KISQALI (ribociclib). Summary of Product Characteristics.
Verzenios (abemaciclib). Summary of Product Characteristics.
Slamon DJ et al. Ther Adv Med Oncol. 2023:15:1–16.
Harbeck N, et al. Ann Oncol. 2021: 32:1571–1581.
Hortobagyi GN, et al. Ann Oncol. 2025;36(2):149-157.

Efficacy