Prescribing information

 

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

 

HOW MUCH INVALUABLE TIME CAN YOU OFFER YOUR HR+/HER2– PREMENOPAUSAL aBC PATIENTS?

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

(n=672)
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

(n=672)
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

 

 

CONFIDENCE IN KISQALI

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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