2020-05-28| Trials & Approvals

Novartis’ Kisqali Shows Promising Results in Advanced Breast Cancer Patients with Liver Metastases

by Tulip Chakraborty
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By T. Chakraborty, Ph.D.

Breast cancer is one of the most common causes of cancer in women, resulting in 1 out of 8 patients in the US, developing an invasive condition in their lifetime. In 2020 alone, approximately 42,170 patients are projected to die [1].

Cyclin-dependent kinases (CDKs) are a family of protein kinases that are involved in cell cycle progression and cell division. The hyperactivated CDK 4 and CDK 6 proteins in metastatic breast cancer cells cause tumors to divide and propagate without control. Therefore, targeted therapy against CDK4/6 has been used to treat metastatic breast cancers [2]. Kisqali (ribociclib) is a CDK4/6 inhibitor developed by Novartis in collaboration with Astex Pharmaceuticals for the treatment of advanced breast cancer.


The Drug

Based on the strong results from the MONALEESA-2 trial, Kisqali was approved first by the FDA and then by the European Commission (EC) in the year 2017. Since then, other combination therapies involving this inhibitor have also been FDA approved.

MONALEESA-3 is a Phase 3 trial conducted in 726 men and postmenopausal women with advanced breast cancer while MONALEESA-7 was conducted in 672 premenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer. Patients were treated either with only endocrine therapy or a combination with Kisqali. Both these trials showed an improvement in overall survival and an increase in progression-free survival [3,4,5].


New Data

On 27th May, Novartis announced that a subgroup analysis from these two clinical trials combined showed that combination therapy of Kisqali with endocrine therapy, extended the life span of women patients with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) by 37%-47% in advanced cases with liver metastases. Liver and brain metastases have been traditionally hard to treat in advanced cancer patients. This new data gives a ray of hope to patients with advanced metastatic breast cancer.

Additionally, Novartis is currently conducting Phase 3 clinical trials (named as NATALEE) with Kisqali to treat early breast cancer in collaboration with Translational Research In Oncology (TRIO)

Denise Yardley, MD, Principal Investigator, Sarah Cannon Research Institute said, “The analysis, looking across two Phase 3 trials, supports the use of Kisqali in the first-line setting regardless of menopausal status or metastatic location. Patients with visceral metastases generally face worse prognosis and a higher risk for treatment resistance, so the consistent overall survival results with Kisqali combination therapy for these patients is compelling.”

Dr. Susan Schaffert, President of Novartis Oncology, noted, “Superior overall survival with Kisqali is proven in two Phase 3 trials, and this subgroup analysis shows that Kisqali could make a difference in survival even among patients with the most aggressive forms of advanced breast cancer. Patients are the inspiration behind everything we do, and we will continue to pursue bold treatment advancements that help reimagine the future for people with cancer in hopes that they can live longer and better.” [7]

In addition to these exciting findings, the presentation at ASCO20 Virtual Scientific Program will include updates from the CompLEEment-1 study, a Phase 3b single-arm trial of 3,246 patients, as well as the economic burden on patients from the adverse effects induced by CDK4/6 inhibitors. Furthermore, an analysis of 550 cancer-related genes, which can be used as biomarkers to study the efficacy and resistance to Kisqali, will also be discussed.



Other than Kisqali, two other CDK1/2 inhibitors, namely Ibrance and Verzenio, have been approved for metastatic breast cancer treatments. Ibrance was the first CDK4/6 inhibitor to be approved by Pfizer, while Verzenio was developed by Eli Lilly. Even though these CDK4/6 inhibitors are the right direction towards targeted cancer therapy, it is to be noted that these drugs may have harmful side effects, including serious lung diseases [7].

Editor: Rajaneesh K.Gopinath, Ph.D.

Related Article: Seattle Genetics Enters Breast Cancer Market with Tukysa



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