A new set of statistically significant overall survival (OS) data unveiled at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract# LBA1008), and published in The New England Journal of Medicine, are being heralded as a major breakthrough for pre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer premenopausal women with advanced breast cancer.
Kisqali was discovered and developed by the Novartis Institutes for Biomedical Research (NIBR) under a research collaboration entered into with Astex in 2005. Kisqali is a CDK4/6 inhibitor that slows the progression of cancer by inhibiting two proteins (CDK4 & CDK6) which, when over-activated, can enable cancer cells to grow and divide quickly.
Successful results from the phase III MONALEESA-7 clinical trial resulted in Kisqali receiving marketing approval in the US and EU in 2018 in combination with an endocrine-based therapy for pre- and perimenopausal women with (HR+/HER2-) locally advanced or metastatic breast cancer in combination with an aromatase inhibitor.
The UK’s National Institute for Health and Care Excellence (NICE) recommended Kisqali as a cost-effective treatment option for postmenopausal women within England and Wales with advanced breast cancer in November 2017. Advanced breast cancer in premenopausal women is the leading cause of cancer death in women 20-59 years old ,.
Kisqali is the only CDK4/6 inhibitor to show superior overall survival in a clinical trial (alt. “v. placebo”) in advanced breast cancer (HR=0.712; p=0.00973). In its announcement at ASCO, Novartis noted that the new data from its MONALEESA-7 trial showed that after a median of 42 months follow-up, survival rate for women was 70.2% for women who received Kisqali combination therapy compared to 46.0% for women who received endocrine therapy alone. The breakthrough data has been widely reported in the world’s press.
Harren Jhoti PhD, President and CEO of Astex, UK, said, “It’s fantastic to see such a significant advance in cancer treatment. Ultimately as life science entrepreneurs, our goal is to improve lives through the discovery of new therapies. Kisqali was the first new cancer drug discovered and developed from our collaboration with Novartis to reach marketing approval and was a milestone for the company in 2017. These new data are a real milestone for patients.”
The paper, Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer, was published in The New England Journal of Medicine and is available online.
 Benz CC. Impact of aging on the biology of breast cancer. Crit Rev Oncol Hematol. 2008;66:65-74.
 World Health Organization. Top cancer per country, estimated age-standardized mortality rates (World) in 2018, females, all ages. 2018. Available at http://gco.iarc.fr/today/home. Accessed May 2019
 Hurvitz S, Seock-Ah I, Yen-Shen L et al. Phase III MONALEESA-7 trial of premenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with endocrine therapy ± ribociclib: Overall survival (OS) results. Presented at the 2019 ASCO Meeting, June 1, 2019, Abstract# LBA 1008.