Prescribing information

 

In premenopausal women with HR+/HER2− aBC, KISQALI + NSAI + LHRH agonist has been shown to improve/maintain QoL vs placebo + NSAI + LHRH agonist.1

Median TTD ≥10% in global health-related QoL in MONALEESA-7

 

 

HR 0.69 (95% CI: 0.52-0.91)1

Longer PFS and improved QoL with KISQALI + NSAI + LHRH agonist vs placebo + NSAI + LHRH agonist may be driving factors behind longer TTD ≥10% in global health status.1

The EORTC QLQ-C30 questionnaire was used to assess the QoL patient-reported outcomes endpoint, which was defined as the time to deterioration of the global health status/QoL scale score of the EORTC by ≥10%.1

KISQALI + ET* HELPS GIVE PATIENTS QUALITY TIME AND IMPROVES OR MAINTAINS MEASURES SUCH AS PAIN, FATIGUE AND GASTROINTESTINAL SYMPTOMS1–6

 

  Premenopausal with AI/tamoxifen*

MONALEESA-7 (N=672)
Postmenopausal with fulvestrant

MONALEESA-3 (N=726)
Postmenopausal with AI

MONALEESA-2 (N=668)
 
Quality of life4–6 In all trials, QoL was improved or maintained vs baseline or placebo, and there was no significant difference between the arms in median TTD of global health status/QoL by ≥10%. At disease progression or EOT, overall QoL worsened in both arms
Pain scores3–6 In all trials, pain was improved or maintained vs baseline or placebo
Overall fatigue4–6 In MONALEESA-7, fatigue was improved or maintained vs placebo. In MONALEESA-3 and MONALEESA-2, no clinically meaningful difference vs placebo
Diarrhoea and nausea/vomiting4–6 In all trials, no clinically meaningful difference vs placebo
No compromise or impairment in activity or work productivity4 N/A N/A In MONALEESA-7, no clinically meaningful difference vs placebo

 

KEY   Maintained   Improved or maintained  N/A Not assessed

* KISQALI is not recommended to be used in combination with tamoxifen.2

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 (n=335) or placebo orally once daily (3 weeks on/1 week off) (n=337) + 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).2,7 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 of EORTC QLQ-C30 and safety.7,8

MONALEESA-2: N=668, double-blind, placebo-controlled, 1:1 randomisation, multicentre, phase III trial in postmenopausal women with HR+/HER2− aBC. As 1L in advanced disease. No prior endocrine therapy for aBC. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg continuous).9 The primary endpoint was locally assessed progression-free survival and the key secondary endpoint was overall survival. Other secondary endpoints included the overall response rate (complete or partial response), the clinical benefit rate (overall response plus stable disease lasting 24 weeks or more), safety, and quality-of-life assessments.9

MONALEESA-3: N=726, double-blind, placebo-controlled, 2:1 randomisation. As 1L and 2L in advanced disease plus those with early relapse. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + 500 mg fulvestrant.10,11 The primary endpoint was locally assessed progression-free survival. Secondary endpoints included overall survival (OS), overall response rate (ORR), clinical benefit rate, and safety and tolerability.10

 

GIVING MORE TIME

Find out more about KISQALI’s overall survival (OS) data and study design (MONALEESA-7)

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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.2

1L, first line; AI, aromatase inhibitor; CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; EORTC QLQ-C30,  European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire; HR, hazard ratio; HR+/HER2−, hormone receptor-positive/human epidermal growth factor 2-negative; LHRH, luteinising hormone-releasing hormone; NSAI, non-steroidal aromatase inhibitor; PFS, progression-free survival; QoL, quality of life; TTD, time to deterioration.

  1. Harbeck N, et al. Ther Adv Med Oncol. 2020;12:1758835920943065. 
  2. KISQALI (ribociclib). Summary of Product Characteristics. 
  3. Beck JT, et al. P6-18-14. Presented at 2018 San Antonio Breast Cancer Symposium, 4–8 December 2018, San Antonio, USA. 
  4. Harbeck N, et al. Abstract 2910. Presented at ESMO 2018 Congress, 19–23 October 2018, Munich, Germany.
  5. Verma S, et al. Breast Cancer Res Treat. 2018;170(3):535–545. 
  6. Fasching PA, et al. Presented at European Society for Medical Oncology Congress, 19–23 October 2018, Munich, Germany. 
  7. Im S-A, et al. N Engl J Med. 2019;381(4):307–316.
  8. Tripathy D, et al. Lancet Oncol. 2018;19(7):904–915.
  9. Hortobagyi GN, et al. N Engl J Med. 2016;375(18):1738–1748.
  10. Slamon DJ, et al. J Clin Oncol. 2018;36(24):2465–2472.
  11. Slamon DJ, et al. N Engl J Med. 2020;382(6):514–524.
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UK | July 2021 | 126173
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