Prescribing information


Young age is an independent factor associated with higher risk of relapse and death for women diagnosed with breast cancer1



KISQALI + ET* is the only CDK4/6i to show statistically significant improvements in OS in three Phase III trials2–4


MONALEESA-7: N=672, Phase III, double-blind, placebo-controlled, 1:1 randomisation in premenopausal 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) + NSAI (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).3,5 The primary endpoint was investigator-assessed progression-free survival. The key secondary endpoint was overall survival, defined as the time from randomisation to death from any cause. The other secondary endpoints included: proportion of patients who achieved an objective response, clinical benefit, time to response, duration of response, time to definitive deterioration of ECOG performance status from baseline, time to 10% deterioration for EORTC QLQ-C30 and safety.3,5

*KISQALI is not recommended to be used in combination with tamoxifen.6

Median overall survival was extended with KISQALI + NSAI + LHRH agonist vs placebo + NSAI + LHRH agonist3

The only CDK4/6 inhibitor that offers a longer OS when combined with NSAI + LHRH agonist vs placebo + NSAI + LHRH agonist in a Phase III clinical trial of premenopausal women3


MONALEESA-7: Prespecified subgroup analysis (N=495) of OS with KISQALI + NSAI + LHRH agonist vs placebo + NSAI + LHRH agonist3

Kaplan-Meier graph showing Prespecified subgroup analysis of median overall survival of patients treated with KISQALI + NSAI vs placebo + NSAI

Adapted from Im S-A, et al. 2019.3

Estimated OS for KISQALI + NSAI + LHRH agonist at 42 months was 69.7% (95% CI: 61.3–76.7) (n=248) vs 43.0% in the placebo + NSAI + LHRH agonist group (95% CI: 25.9–59.0) (n=247).3

No statistical test was performed for the subgroup of patients receiving NSAI as the combination partner.3


MONALEESA-7: OS in HR+/HER2− premenopausal aBC patients in an exploratory analysis with a median follow-up of 54 months.7

Kaplan-Meier graph showing Median OS in HR+/HER2− premenopausal aBC women in an exploratory analysis with a median follow-up of 54 months.

Adapted from Lu Y-S, et al. 2022.7

These results come from exploratory OS analysis updates and are not pre-specified and are observational in nature; as such, there was no pre-specified statistical procedure controlling for type 1 error.

Results should be interpreted with caution due to the limitation of exploratory analysis.

The ITT population included all patients (n=672) randomised to KISQALI or placebo with either tamoxifen* or an NSAI, both with goserelin5


  KISQALI arm Placebo arm
Primary endpoint: progression-free survival5
ITT population

23.8 months

(95% Cl: 19.2–NR)
13.0 months

(95% CI: 11.0–16.4)
HR 0.55 (95% Cl: 0.44–0.69), p<0.0001
KISQALI or placebo + NSAI

+ LHRH agonist subgroup (n=495)
27.5 months

(95% Cl: 19.1–NR)
13.8 months

(95% Cl: 12.6–17.4)
HR 0.57 (95% Cl: 0.44–0.74)
key secondary endpoint: overall survival3
ITT population

Significantly increased in the KISQALI arm vs the placebo arm,

HR 0.71 (95% CI: 0.54–0.95), p=0.00973


*KISQALI is not recommended to be used in combination with tamoxifen.6




Learn about QoL outcomes


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.*6

*KISQALI is not recommended to be used in combination with tamoxifen6

1L, first line; aBC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6, cyclin-dependent kinase 4 and 6; CI, confidence interval; HR, hazard ratio; HR+/HER2−, hormone receptor-positive/human epidermal growth factor receptor 2-negative; ITT, intention-to-treat; LHRH, luteinising hormone-releasing hormone; mOS, median overall survival; NR, not reached; NSAI, non-steroidal aromatase inhibitor; OS, overall survival; PBO, placebo; QoL, quality of life; RIB, ribociclib.

  1. Azim Jr HA and Partridge AH. Breast Cancer Res. 2014;16:427.
  2. Hortobagyi GN, et al. N Engl J Med. 2022;386(10):942–950.
  3. Im SA, et al. N Engl J Med. 2019;381(4):307–316.
  4. Slamon DJ, et al. N Engl J Med. 2020;382(6):514–52.
  5. Tripathy D, et al. Lancet Oncol 2018;19(7):904–915.
  6. KISQALI (ribociclib). Summary of Product Characteristics.
  7. Lu Y-S, et al. Clin Cancer Res 2022;2(5):851–859.


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UK | August 2022 | 231468

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