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Spotlight: Novartis’ Kisqali Shows Promising Results in Metastatic Breast Cancer
On December 9th, Novartis announced encouraging updates from its Phase III clinical trial, MONALEESA-7, at the San Antonio breast cancer virtual symposium. The trial demonstrated that the CDK4/6 inhibitor Kisqali showed encouraging results in metastatic breast cancer patients. Breast cancer affects 1 in 8 women in their lifetime. In 2020 alone, 276,000 new cases of breast cancer are projected to be diagnosed, and 42,000 patients will succumb to the disease. This is the most common type of cancer amongst women besides lung cancer. Treatments for breast cancer include endocrine therapy, chemotherapy, among others. 
Kisqali is a cyclin-dependent kinase (CDK) 4/6 inhibitor that was developed by Novartis Institutes for BioMedical Research (NIBR) in collaboration with Astex Pharmaceuticals. Cyclin-dependent kinases are important proteins that regulate cell cycles. In tumor cells, these kinases are dysregulated, which leads to uncontrolled cell division and metastasis of cancer cells. Hence, inhibition of these kinases has been touted as potential drug targets. Kisqali received the first FDA approval in 2017, and since then, it has rapidly emerged as one of the major drugs for breast cancer treatments. 
MONALEESA-7 is a randomized, double-blinded, Phase III clinical trial that tested the efficacy and safety of Kisqali in metastatic cancer patients. Around 670 patients were enrolled in the study. The update from this trial showed that Kisqali treatment increased the overall survival in patients to almost 5 years. This is almost 25% higher than endocrine therapy alone as well as an aromatase inhibitor. The drug treatment also increased the time to 50.9 months before chemotherapy is required, compared to 36 months with endocrine therapy alone. Kisqali is currently in clinical trials to treat previously untreated patients, and the data is expected in 2021.
Dr. Debu Tripathy, Chair of Breast Medical Oncology at MD Anderson Cancer Center, said, “These longer-term data showing ribociclib can help women with metastatic breast cancer live longer are remarkable and emphasize the progress we’ve made in treating this disease, which until now, had an estimated median survival of just three years. I’m hopeful the proven overall survival benefit with ribociclib will shift the standard for those with metastatic breast cancer, and that patients are empowered to ask their doctors about which treatments give them the best chance of living longer with the best quality of life.”
Dr. Susanne Schaffert, President, Novartis Oncology, added, “We’re proud to be able to provide the CDK4/6 inhibitor with the longest ever reported median overall survival benefit of nearly five years in younger women. It is our vision to develop therapies that give patients the longest life possible, and these best-in-class data help us realize that vision by proving Kisqali extends the lives of younger premenopausal women with metastatic breast cancer, who typically have more aggressive disease and unique needs.” 
The major competitor to Kisqali is Pfizer’s blockbuster drug Ibrance, and Eli Lilly’s Verzenio. Kisqali was approved two years after Ibrance, thus giving Pfizer the edge in the market. However, in recent times Verzenio and Kisqali have gained some ground on Ibrance. Ibrance failed a clinical trial in early breast cancer patients, while Verzenio was successful in a similar trial. Further, Kisqali was able to increase the survival in HER 2-enriched breast cancer patients where Ibrance failed. Though all three drugs target the Cdk4/6, the affinity of Kisqali and Verzenio is more towards Cdk4 while Ibrance has an affinity towards Cdk6. Thus, the recent success of Kisqali and Verzenio may be due to the abundance of Cdk4 in breast cancer cells. Though Pfizer is the leader in this indication, it will be interesting to see if Novartis and Eli Lilly can catch up.
By T. Chakraborty, Ph.D.
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