Results from the NATALEE pre-specified 6-year analysis

KISQALI + ET:* overall survival (OS) data across all Phase III trials in advanced and early breast cancer^†2–5

In a pre-specified 6-year analysis of the NATALEE trial, an OS benefit was observed with KISQALI + NSAI vs NSAI alone in patients with HR+/HER2– eBC²

Adapted from Slamon D, et al. 2026.²

178 and 205 OS events for KISQALI + NSAI (n=2549) and NSAI alone (n=2552) arms, respectively. Nominal log-rank p-value (descriptive in nature). Median follow-up of 66.5 months.²

At 6 years, invasive disease-free survival (iDFS) and distant disease-free survival (DDFS) benefits were sustained with KISQALI + NSAI vs NSAI alone²

iDFS at 6 years²

In NATALEE, iDFS was a primary endpoint.^‡6

DDFS at 6 years²

In NATALEE, DDFS was a secondary endpoint.⁶

Adapted from Slamon D, et al. 2026.²

DDFS is defined as the time from date of randomisation to date of first event of distant recurrence, death (any cause), or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).^6,9

344 and 423 DDFS events for KISQALI + NSAI (n= 2549) and NSAI alone (n=2552) arms, respectively. Nominal log-rank p-value (descriptive in nature). Median follow-up of 66.3 months.²

KISQALI has the broadest indication of CDK4/6is in HR+/HER2– eBC, offering you the opportunity to treat a broad range of eligible patients¹

KISQALI in combination with an AI is indicated for the adjuvant treatment of patients with HR+/HER2– eBC at high risk of recurrence. This includes patients with lymph node positive cancer, or if no nodal involvement, either tumour size >5 cm, or tumour size 2–5 cm with either grade 2 (and high genomic risk or Ki-67 ≥20%) or grade 3. In pre/perimenopausal women, or in men, the AI should be combined with a LHRH agonist. KISQALI is not recommended for use in combination with tamoxifen.¹

In HR+/HER2– eBC, news worth sharing

KISQALI has a well-characterised and generally manageable safety profile¹

The most common adverse drug reactions (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.¹

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

Dose reduction due to adverse events, regardless of causality, occurred in 22.8% of patients receiving KISQALI + AI in the Phase III clinical study. Permanent discontinuation was reported in 19.7% of patients receiving KISQALI + AI in the Phase III clinical study.¹

Please refer to the SmPC for further information on safety profile.

*ET is defined as AI or fulvestrant.^3–5
†In HR+/HER2− aBC, 1L KISQALI + ET  has shown OS benefit. ET is defined as AI or fulvestrant and LHRH.^3–5 MONALEESA-2: At median 80-month follow-up, KISQALI + AI achieved mOS of 63.9 months vs 51.4 months with placebo + AI (HR=0.76; 95% CI: 0.63–0.93; p=0.008).³ MONALEESA-3: At median 71-month follow-up, KISQALI + fulvestrant achieved mOS of 52.5 months vs 41.5 months with placebo + fulvestrant (HR=0.75; 95% CI: 0.62–0.92).⁴ MONALEESA-7: At median 54⁠-⁠month follow-up, KISQALI + AI achieved mOS of 58.7 months vs 47.7 months with placebo + AI (HR=0.8; 95% CI: 0.62–1.04).⁵ OS benefit in the pre-specified 2nd interim analysis: HR=0.70; 95% CI: 0.50⁠–⁠0.98.^14
‡The primary endpoint of the NATALEE study was met (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-value=0.0014) was demonstrated in patients receiving KISQALI + NSAI vs NSAI alone.^1

§N0 high-risk defined as T3-4N0 disease, T2N0 grade 2 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 grade 3.^9
¶In eBC: ESMO-MCBS score of A^AT for KISQALI + NSAI (NATALEE study).¹⁰ Score range A–C, where A is the highest and B indicates substantial benefit in the curative setting. The criteria for AT annotation of the experimental arm include >30% prevalence of grade 3 or higher AEs impacting well-being, premature discontinuation of therapy due to AEs in >10% of patients, or hospitalisation for toxicity in >10% of patients.^12
‖ESMO-MCBS scores are based on peer reviewed clinical trial reports. They are generated using a validated standard methodology and are reviewed by a team of clinicians and statisticians before publication. The ESMO-MCBS facilitates clinical decision-making by rating clinically meaningful benefit of cancer medicines from published data. ESMO-MCBS scores should be interpreted in the context of an evolving treatment landscape, in connection with clinical practice guidelines.^12,15
 
MONALEESA-2: N=668; double-blind, placebo-controlled, 1:1 randomised, multicentre, Phase III trial in postmenopausal women for 1L treatment of HR+/HER2– aBC. KISQALI 600 mg/d or placebo orally (3 weeks on/1 week off) + AI. Primary endpoint was progression-free survival (PFS); key secondary endpoint was OS.³



MONALEESA-3: N=726; double-blind, placebo-controlled, 2:1 randomised, Phase III trial in postmenopausal women for 1L or 2L treatment of HR+/HER2– aBC plus those with early relapse. KISQALI 600 mg/d or placebo orally (3 weeks on/1 week off) + 500 mg intramuscular fulvestrant (Day 1 of every 28-day cycle, with an additional dose on Day 15 of Cycle 1). Primary endpoint was PFS; key secondary endpoint was OS.⁴



MONALEESA-7: N=672; double-blind, placebo-controlled, 1:1 randomised, Phase III trial in pre- or perimenopausal women for 1L treatment of HR+/HER2– aBC in patients who received ≤1 lines of chemotherapy for aBC. KISQALI 600 mg/d or placebo orally (3 weeks on/1 week off) + AI or tamoxifen 20 mg orally once daily continuously + LHRH agonist (goserelin 3.6 mg subcutaneously on Day 1 of every cycle). Primary endpoint was PFS; key secondary endpoint was OS.⁵ KISQALI should not be co-administered with tamoxifen.¹

NATALEE: N=5101; multicentre, randomised, open-label Phase III clinical trial of KISQALI + NSAI vs NSAI alone in the adjuvant treatment of HR+/HER2 eBC. KISQALI 400 mg/d + NSAI for 3 years while NSAI was continued for ≥5 years. Any (neo)adjuvant ET was permitted for <1 year prior to randomisation. Primary endpoint was iDFS; secondary endpoints were DDFS and OS.^2,6

1L, first line; 2L, second line; aBC, advanced breast cancer; ADR, adverse drug reaction; AE, adverse event; AI, aromatase inhibitor; AJCC, American Joint Committee on Cancer; ARR, absolute risk reduction; CDK4/6i, cyclin-dependent kinase 4 and 6 inhibitor; CI, confidence interval; DDFS, distant disease-free survival; eBC, early breast cancer; ESMO, European Society for Medical Oncology; ESMO-MCBS, ESMO-magnitude of clinical benefit scale; ET, endocrine therapy; HER2–, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; iDFS, invasive disease-free survival; ITT, intention-to-treat; LHRH, luteinising hormone-releasing hormone; mOS, median overall survival; NSAI, non-steroidal aromatase inhibitor; OS, overall survival; PFS, progression-free survival; SmPC, summary of product characteristics.
 
References

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

2. Slamon D, et al. Presented at the European Society for Medical Oncology Congress. 23–27 October 2026, Madrid, Spain.

3. Hortobagyi GN, et al. N Engl J Med 2022;386(10):942–950.

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

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

6. Hortobagyi GN, et al. Ann Oncol 2025;36(2):149–157.

7. Crown J, et al. ESMO Open 2025;10(11):105858.

8. Riggio AI, et al. Br J Cancer 2021;124(1):13–26.

9. Slamon DJ, et al. Ther Adv Med Oncol 2023;15:1–16.

10. European Society for Medical Oncology. Ribociclib. NATALEE. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards?scorecard=468 [Accessed October 2026].

11. European Society for Medical Oncology. Abemaciclib. monarchE. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards?scorecard=371 [Accessed October 2026].

12. Cherny NI, et al. Ann Oncol 2025;36(8):866–908.

13. Fasching PA, et al. JAMA Oncol 2025;11(11):1364–1372.

14. Im S-A, et al. N Engl J Med 2019;381:307–316.

15. European Society for Medical Oncology. ESMO-MCBS Scorecards. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards [Accessed October 2026].

UK | October 2026 | FA-11805966