From progression-free survival to overall survival with ribociclib
Previously, the MONALEESA studies reported prolonged progression free survival with ribociclib alongside endocrine therapy in women with HR+/HER2- advanced breast cancer.7 Now, the same studies have reported clinically and statistically significant prolongation in overall survival.9–11 Gabriel Hortobagyi, MD, from the University of Texas MD Anderson Cancer Center discusses the potential impact of these results in the treatment of advanced breast cancer.
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Overall survival results from the phase III MONALEESA-2 study
The phase III MONALEESA-2 study showed that adding ribociclib to a backbone of letrozole results in statistically significant median overall survival (OS) of more than 5 years in postmenopausal patients with HR+/HER2- metastatic breast cancer.9 In this video, David Cameron, MD, from Edinburgh Cancer Research Centre discusses the impact of extending OS for his patients with advanced breast cancer and their families.9
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Quality of life and chemotherapy-free survival in the MONALEESA studies
A pooled analysis of data from the three MONALEESA studies indicated quality of life benefits with ribociclib compared with endocrine therapy alone.12 Peter Fasching, MD, from the Comprehensive Cancer Center Erlangen-EMN, Germany, discusses the importance of maintaining quality of life for patients, in addition to improved survival.
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Overview & Learning Objectives
Cyclin-dependent kinases 4 and 6 (CDK4/6) play a key function in regulating cell cycle progression and have a known role in promoting cancer growth.1,2 Three orally available CDK4/6 inhibitors, including ribociclib (KISQALI®) are now available in Europe for people with HR+/HER2- advanced or metastatic breast cancer.3–8 Now, overall survival (OS) results have been reported from the phase III MONALEESA-2 trial, showing median OS beyond 5 years in postmenopausal patients with HR+/HER2- advanced breast cancer treated with ribociclib and endocrine therapy.9
After watching this activity, participants should be better able to:
- Recognise the role of CDK4 versus CDK6 inhibition in metastatic breast cancer growth
- Discuss the overall survival results from the MONALEESA-2 study and the potential impact for patients
- Describe the quality of life benefits of ribociclib from a pooled analysis of the MONALEESA studies
- O'Leary B, Finn RS, Turner NC. Treating cancer with selective CDK4/6 inhibitors. Nat Rev Clin Oncol. 2016;13(7):417–30.
- Hosford SR, Miller TW. Clinical potential of novel therapeutic targets in breast cancer: CDK4/6, Src, JAK/STAT, PARP, HDAC, and PI3K/AKT/mTOR pathways. Pharmgenomics Pers Med. 2014;7:203–15.
- European Medicines Agency. Ibrance (palbociclib) European Public Assessment Report (EPAR). 2022. Available at: www.ema.europa.eu/en/medicines/human/EPAR/ibrance (accessed March 2022)
- European Medicines Agency. Verzenios (abemaciclib) EPAR. 2022. Available at: www.ema.europa.eu/en/medicines/human/EPAR/verzenios (accessed March 2022)
- European Medicines Agency. Kisqali (ribociclib) EPAR. 2021. Available at: www.ema.europa.eu/en/medicines/human/EPAR/kisqali (accessed March 2022)
- Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2- negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016; 17: 425–39.
- Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375:1738–48.
- Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35:3638–46.
- Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med. 2022;386:942–50.
- Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382(6):514–24.
- Lu YS, Im SA, Colleoni M, et al. 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. Clin Cancer Res. 2022;28(5):851–9.
- Fasching PA, Bardia A, Nusch A, et al. Pooled analysis of patient-reported quality of life in the MONALEESA-2, -3, and -7 trials of ribociclib plus endocrine therapy to treat hormone receptor–positive, HER2-negative advanced breast cancer. Ann Oncol. 2020;31(4_suppl). Abstract 2760.