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Indications:1,2
- KISQALI® (ribociclib) 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
KISQALI is not recommended to be used in combination with tamoxifen.
KISQALI + AI has the highest clinical ESMO-MCBS rating of any CDK4/6i + AI used in 1L postmenopausal patients with HR+/HER2– aBC3
The ESMO-MCBS is a standardised tool that quantifies the likely magnitude of clinical benefit. The scale highlights treatments which substantially improve the duration of survival and/or the quality of life of patients in the non-curative setting, ranging from grades 1 to 5, with 4 and 5 denoting substantial benefit.4
The scale considers overall survival, progression-free survival, disease-free survival, hazard ratio, response rate, quality of life, prognosis of the condition and toxicity.4
ESMO-MCBS scores of CDK4/6is in 1L postmenopausal patients3
No head-to-head comparison is available, comparison within class shouldn’t be made. Caution should be taken due to differences in patient population and trial designs.
| Tested agent | Combined agent | Control arm | Tumour type, subtype and subgroup | ESMO-MCBS score |
|---|---|---|---|---|
| KISQALI | Letrozole | Letrozole + placebo | HR+/HER2– aBC | 4 |
| Abemaciclib | AI | AI + placebo | HR+/HER2– aBC | 3 |
| Palbociclib | Letrozole | Letrozole + placebo | HR+/HER2– aBC | 3 |
In pre- and postmenopausal HR+/HER2− aBC patients:
KISQALI + ET* currently holds a rating of 5/5 as a treatment for 1L premenopausal patients3
KISQALI + AI currently holds a rating of 4/5 for 1L postmenopausal HR+/HER2– aBC patients3
KISQALI + fulvestrant currently holds a rating of 4/5 for 1L or 2L postmenopausal patients3
KISQALI + ET* is the only CDK4/6i that achieved statistically significant OS results vs placebo + ET across three Phase III trials in HR+/HER2– aBC patients (secondary endpoint)5–10
In a pooled analysis of the three MONALEESA trials, KISQALI + ET* maintained QoL in the global health score relative to placebo + ET (secondary endpoint)11
KISQALI has a generally manageable safety profile, regardless of patient menopausal status5–10,12–14
*KISQALI is not recommended to be used in combination with tamoxifen.1,2
Across all three MONALEESA trials, PFS was the primary endpoint and OS and QoL were the secondary endpoints.
1L, first-line; 2L, second-line; aBC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; EORTC, European Organisation for Research and Treatment of Cancer; ESMO-MCBS, European Society for Medical Oncology Magnitude of Clinical Benefit Scale; ET, endocrine therapy; HER2–, human epidermal growth receptor 2 negative; HR, hazard ratio; HR+, hormone receptor positive;LHRH, luteinising hormone-releasing hormone; mTTD, median time-to-deterioration; OS, overall survival; PFS, progression-free survival; QoL, quality of life; TTD, time-to-deterioration.
References:
- KISQALI® (ribociclib) Great Britain Summary of Product Characteristics.
- KISQALI® (ribociclib) Northern Ireland Summary of Product Characteristics.
- European Society for Medical Oncology. ESMO-MCBS Score cards for HR+/HER2– breast cancer. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/es... [Accessed February 2024].
- European Society for Medical Oncology. ESMO-magnitude of clinical benefit scale. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/es... [Accessed February 2024].
- Hortobagyi GN, et al. Oral presentation. ESMO Congress 2021, 16–21 September 2021, virtual.
- Hortobagyi GN, et al. N Engl J Med 2022;386(10):942–950.
- Im S-A, et al. N Engl J Med 2019;381(4):307–316.
- Tripathy D, et al. Lancet Oncol 2018;19(7):904–915.
- Slamon DJ, et al. J Clin Oncol 2018;36(24):2465–2472.
- Slamon DJ, et al. N Engl J Med 2020;382(6):514–524.
- Fasching PA, et al. Oral presentation. European Society for Medical Oncology Breast Cancer Congress; 5–8 May 2021, virtual.
- Lu Y-S, et al. Clin Cancer Res 2022;2(5):851–859.
- Hortobagyi GN, et al. N Engl J Med 2016;375(18):1738–1748.
- Tripathy D, et al. Poster 166P. European Society for Medical Oncology. 2–4 May 2019, Berlin, Germany.