Advanced breast cancer guideline recommendations for KISQALI® (ribociclib)

Advanced breast cancer (aBC) is a virtually incurable disease associated with poor prognosis:^3,4

• A median OS of 3 years

• 5-year survival rate of 25%

HR+/HER2– aBC is the most common subtype of metastatic breast cancer.⁴

Treatment is aimed at improving overall survival, in addition to maintaining or improving quality of life.⁴ Although the disease remains incurable, the availability of systemic therapies such as endocrine therapy* (ET) has led to improvements in the management of this hormone-sensitive disease.⁵

Cyclin-dependent kinases 4 and 6 (CDK4/6) play a key role in cell cycle progression and have become an effective target in the treatment of aBC.⁶

ESMO clinical practice guidelines for the treatment of ER+/HER– mBC

Adapted from ESMO Metastatic Breast Cancer Living Guidelines, v1.1 May 2023.⁷

Orange: general categories or stratification; light teal: combination of treatments or other systemic treatments; white: other aspects of management; dark teal: systemic anticancer therapy.

(a) OFS if the patient is premenopausal.
(b) If relapse <12 months after end of adjuvant AI: fulvestrant–CDK4/6 inhibitor (a); if relapse >12 months after end of adjuvant AI: AI–CDK4/6 inhibitor.
(c) Preferred if the patient is ESR1 mutation positive [ESCAT score: II-A].
(d) ESMO-MCBS v1.1 was used to calculate scores for new therapies/indications approved by the EU and US. The scores have been calculated by the ESMO-MCBS Working Group and validated by the ESMO Guidelines Committee.^8,9
(e) ESCAT scores apply to genomic alterations only. These scores have been defined by the guideline authors and validated by the ESMO Translational Research and Precision Medicine Working Group.¹⁰
(f) Trastuzumab deruxtecan can also be given following adjuvant ChT in the setting of fast progression (DESTINY-Breast04/EMA indication).

*KISQALI is not recommended to be used in combination with tamoxifen.^1,2
†Everolimus is not licensed in combination with fulvestrant or for use in premenopausal women. Novartis does not condone the off-label use of therapies. Please refer to individual Summary of Product Characteristics before prescribing.
^‡In Great Britain, alpelisib is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine-based therapy. In Northern Ireland, alpelisib is only indicated following endocrine-based monotherapy. Please note the positioning of alpelisib after combination therapy with ET and CDK4/6i in the ESMO guidelines falls outside of the licence in Northern Ireland. Please consult the relevant Summary of Product Characteristic before prescribing.

1L, first-line; aBC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4/6-inhibitor; ChT, chemotherapy; EMA, European Medicines Agency; ER, oestrogen receptor; ESCAT, ESMO Scale for Clinical Actionability of Molecular Targets; ESMO, European Society for Medical Oncology; ESMO-MCBS, European Society for Medical Oncology Magnitude of Clinical Benefit Scale; ESR1, oestrogen receptor 1; ET, endocrine therapy; FDA, Food and Drug Administration; HER2–, human epidermal growth receptor 2 negative; HR+, hormone receptor positive; LHRH, luteinising hormone-releasing hormone; m, mutation; mBC, metastatic breast cancer; MCBS, ESMO-Magnitude of Clinical Benefit Scale; OFS, ovarian function suppression; PALB2, partner and localiser of BRCA2; PARP, poly ADP-ribose polymerase; PD, progressive disease; PIK3CA, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha.

References

1. KISQALI® (ribociclib) Great Britain Summary of Product Characteristics.
2. KISQALI® (ribociclib) Northern Ireland Summary of Product Characteristics.
3. Cardoso F, et al. Ann Oncol 2020;31(12):1623–1649 and Supplementary material.
4. Hortobagyi GN, et al. N Engl J Med 2022;386:942–950.
5. McAndrew NP, et al. JCO Oncol Prac 2021;18(5):319–327
6. Slamon DJ, et al. Annals Oncol 2021;32(8):1015–1024.
7. European Society for Medical Oncology. ESMO Metastatic Breast Cancer Living Guidelines, v1.1 May 2023. Available at: https://www.esmo.org/living-guidelines/esmo-metastatic-breast-cancer-liv... [Accessed March 2024].
8. Cherny NI, et al. Ann Oncol 2017;28(10):2340–2366.
9. European Society for Medical Oncology. ESMO-MCBS Evaluation forms. Available at: https://www.esmo.org/guidelines/esmo-mcbs/ esmo-mcbs-for-solid-tumours/esmo-mcbs-evaluation-forms [Accessed March 2024].
10. Mateo J, et al. Ann Oncol 2018;29(9):1895–1902.
11. 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 March 2024].