1. Medicines
  2. KISQALI®▼ (ribociclib)
  3. PREMENOPAUSAL WOMEN WITH aBC HAVE INDIVIDUAL NEEDS:
  4. Giving more time with KISQALI®▼

Prescribing information

 

Please note that the black triangle (▼) and associated additional monitoring activities required for Kisqali®, only applies to its marketing authorisation in Great Britain. It is NOT applicable to the marketing authorisation of Kisqali® in Northern Ireland.

 

Giving more time with KISQALI®▼

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

Young age is an independent factor associated with higher risk of relapse and death1
 

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

KISQALI + NSAI + LHRH agonist is the only CDK4/6 inhibitor that offers statistically significant longer OS than placebo + NSAI + LHRH agonist for HR+/HER2− premenopausal aBC patients2–4

 

 

MONALEESA-7: N=672, 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) + AI (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).2,5 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 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.2,6

KISQALI is not recommended to be used in combination with tamoxifen.5

Median overall survival was extended with KISQALI + NSAI vs placebo + NSAI2

The only CDK4/6 inhibitor that offers statistically significant longer OS than placebo + NSAI +LHRH agonist for HR+/HER2− premenopausal aBC patients2–4

 

MONALEESA-7: Prespecified subgroup analysis (N=495) of OS with KISQALI + NSAI + LHRH agonist vs placebo + NSAI + LHRH agonist2

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. 2019.2

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).2

 

MONALEESA-7: OS in HR+/HER2− premenopausal aBC women in an exploratory analysis with a median follow-up of 54 months7

Kaplan-Meier graph showing Median OS in HR+/HER2− premenopausal aBC women in an exploratory analysis with a median follow-up of 54 months5.

Adapted from Tripathy D, et al. 2020.7

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 goserelin6

 

  KISQALI arm Placebo arm
Primary endpoint: progression-free survival6
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 survival2
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.5

 

'YOU CAN GIVE YOUR PATIENTS MORE TIME WORTH HAVING

 

CONFIDENCE IN KISQALI

Learn about QoL outcomes

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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.5

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 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. Im S-A, et al. N Engl J Med. 2019;381(4):307–316. 
  3. Finn RS, et al. Breast Cancer Res Treat. 2020;183:419–428. 
  4. Goetz MP, et al. J Clin Oncol. 2017;35(32):3638–3646. 
  5. KISQALI (ribociclib). Summary of Product Characteristics.
  6. Tripathy D, et al. Lancet Oncol 2018;19(7):904–915.
  7. Tripathy D, et al. Poster PD2-04. Presented at San Antonio Breast Cancer Symposium, 8–12 December 2020; San Antonio, USA. 

 

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UK I July 2021 I 126171
Oncology
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