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Kisqali

 

 

Kisqali provides 5 Years Median Overall Survival for Metastatic HR+ve/HER2-ve breast cancer patients across all phase III Trials regardless of Menopausal status

 

 

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Adapted from ref 1 & 2 & 3

 

Kisqali® Guidelines Summary Recommendations

NCCN
ESMO MCBS

OS is the gold standard endpoint for efficacy measures in oncology trials7
If achieved, statistically significant OS overrides PFS as a surrogate endpoint for survival

FDA

Although PFS can be a possible surrogate for survival, statistically significant improvements in PFS do not always translate to statistically significant improvements in OS10 
due to multiple factors that may influence post-progression survival9 

KISQALI—a long median overall survival reported in HR+/HER2- advanced Breast Cancer

A CDK4/6 inhibitor with statistically signicant overall survival proven across all 3 phase III trials

Adapted from ref 1 & 2 & 3

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image 1

MONALEESA-21: N=668, 1:1 randomization. As 1L in advanced disease. KISQALI 600 mg or placebo once daily (3 weeks on/1 week off) + letrozole 2.5 mg 


MONALEESA-72: N=6724, 1:1 randomization. As 1L in advanced disease. KISQALI 600 mg or placebo once daily (3 weeks on/1 week off) + ET (letrozole 2.5 mg or anastrozole 1 mg,or tamoxifen 20 mg orally) + LHRH agonist 3.6 mg 


MONALEESA-33: N=726, 2:1 randomization. As 1L or after 1L progression for advanced disease. KISQALI 600 mg or placebo once daily (3 weeks on/1 week off) + fulvestrant 500 mg 


KISQALI is not indicated for concomitant use with tamoxifen12

Data

5 Years mOS across all phase III Trials

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Adverse events are Predictable, manageable & Reversible

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Guidelines & Prescribing info

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1L, first line; AI, aromatase inhibitor; CDK, cyclin-dependent kinase; ESMO-MCBS, European Society for Medical Oncology Magnitude of Clinical Benefit Scale; ET, endocrine therapy; mBC, metastatic breast cancer; OS, overall survival; PFS, progression-free survival; QoL, quality of life; FDA, Food and Drug Administration; 2L, second line; ET, endocrine therapy; LHRH, luteinizing hormone-releasing hormone,HR+/HER2- aBC: Hormone Receptor–Positive/Human Epidermal Growth Receptor 2–Negative- advanced Breast Cancer.

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Efficacy - Major trial results
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Efficacy- Further analysis
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Safety and AE management
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Guidelines

For Kisqali Abbreviated prescribing information

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References

  1. Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte P. Overall survival with ribociclib plus letrozole in advanced breast cancer. New England Journal of Medicine. 2022 Mar 10;386(10):942-50.

  2. Lu YS, Im SA, Colleoni M, Franke F, Bardia A, Cardoso F, Harbeck N, Hurvitz S, Chow L, Sohn J, Lee KS. Updated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre-and Perimenopausal Patients with HR+/HER2− Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial Updated Overall Survival Analysis of the MONALEESA-7 Trial. Clinical Cancer Research. 2022 Mar 1:OF1-9.

  3. Slamon DJ, Neven P, Chia S, Jerusalem G, De Laurentiis M, Im S, Petrakova K, Bianchi GV, Martín M, Nusch A, Sonke GS. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Annals of Oncology. 2021 Aug 1;32(8):1015-24.

  4. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Breast Cancer 2025. available at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf . last accessed 3/2/2025

  5. European Society for Medical Oncology (ESMO). ESMO-MCBS Scorecards. Ribociclib scores. available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards?mcbs_score_cards_form%5BsearchText%5D=Ribociclib . last accessed 3/2/2025

  6. European Society for Medical Oncology (ESMO). ESMO-MCBS Evaluation Forms. available at:https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-evaluation-forms .last accessed 3/2/2025

  7. Fiteni F, Westeel V, Pivot X, Borg C, Vernerey D, Bonnetain F. Endpoints in cancer clinical trials. Journal of visceral surgery.
    2014 Feb 1;151(1):17-22.

  8. US Food and Drug Administration. Clinical trial endpoints for the approval of cancer drugs and biologics. Available
    at: https://www.fda.gov/media/71195/download. Accessed 15/6/2025

  9. Broglio KR, Berry DA. Detecting an overall survival benefit that is derived from progression-free survival. JNCI: Journal of
    the National Cancer Institute. 2009 Dec 2;101(23):1642-9.

  10. Korn EL, Freidlin B, Abrams JS. Overall survival as the outcome for randomized clinical trials with effective subsequent
    therapies. Journal of clinical oncology. 2011 Jun 6;29(17):2439.

  11. Lu YS, Im SA, Colleoni M, Franke F, Bardia A, Cardoso F, Harbeck N, Hurvitz S, Chow L, Sohn J, Lee KS. Updated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre-and Perimenopausal Patients with HR+/HER2-Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical TrialUpdated Overall Survival Analysis of the MONALEESA-7 Trial. Supplemental Appendix. Clinical Cancer Research. 2022 Mar 1:OF1-9.

  12. Kisqali. Summary of product characteristics (SMPC). available at: https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf . last accessed 15/6/2025

Approved by Egyptian Drug Authority: HF0082OA4733/082025. Invalidation date: 28/08/2027.
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HF0424OA4807/102025 14/10/2027