The US Food and Drug Administration approved the precision cancer medicine Kisqali® (ribociclib, LEE011) for first line treatment of estrogen hormone receptor positive (ER+), HER 2 negative (HER2-Neg) metastatic breast cancer because when combined with other hormonal therapy the combination benefits all such women and leads to improved survival without cancer recurrence compared to chemotherapy or other standard hormone therapies.
Advanced or metastatic breast cancer refers to cancer that originated in the breast, but has spread to several and/or distant sites in the body. The goals of treatment for metastatic breast cancer are to improve duration of survival while maintaining quality of life.
The majority of breast cancers are referred to as HR+, meaning their cancer is stimulated to grow from exposure to the female hormones estrogen and/or progesterone. These patients are often treated with endocrine therapy (sometimes referred to as hormone, or anti-estrogen therapy), which reduces the cancer cells’ exposure to estrogen through varying mechanisms. Endocrine therapy has proven extremely effective in reducing HR-positive cancer growth and spread for extended periods of time.
Mature results from several clinical trials evaluating Kisqali® continue to show that Kisqali improves outcomes in pre, peri, and post women with ER+ Her2-Neg breast cancer. Adding Kisqali to standard endocrine therapy significantly improves overall survival for women with advanced HR-positive/HER2-negative breast cancer compared with endocrine therapy alone. The combination of a precision cancer medicine and endocrine therapy as a first-line treatment for advanced breast cancer is a new standard of care.
Kisqali is a selective cyclin-dependent kinase inhibitor—this class of drugs helps slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. In July 2018, the U.S. Food and Drug Administration approved an expanded indication for Kisqali to be used in combination with an aromatase inhibitor to include pre- and peri-menopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.
A Kisqali ®Femara ® Co-Pack allows patients the convenience of obtaining a full 28-day cycle of the two medicines in one package with one prescription and one co-pay. The Kisqali-Femara Co-Pack is available at the same cost as Kisqali alone. The Kisqali-Femara Co-Pack will be available in the US later this month at both specialty and retail pharmacies and does not change the indication for either medicine.
Kisqali with or without Fasloex
The Monaleesa-3 clinical trial evaluated 726 postmenopausal patients with ER+, HER2-Neg advanced breast cancer who were treated with Kisqali® + Faslodex (fulvestrant) and compared to treatment with Faslodex alone.1,2 The study demonstrated that the addition of Kisqali delayed cancer progression and prolonged survival. The initial trial results showed significantly longer overall survival in women treated with Kisqali. Longer follow up results were released in the NEJM and at the 2022 European Society Oncology Annual Meeting.9,15,16
After a median follow-up of 56.3 months, average survival for patients taking Kisqali in combination with fulvestrant was 53.7 months vs. 41.5 months for fulvestrant alone.
The need for chemotherapy was delayed to 4 years (48.1 months) in patients taking Kisqali in combination with fulvestrant and 28.8 months in the patients taking fulvestrant alone.
Extended follow-up data showed that the estimated survival rate at five years was 56.5% for women who received the Kisqali fulvestrant combination treatment compared to 42.1% for women who received fulvestrant alone.
Kisqali with or without Femara
The Monaleesa-2 clinical trial directly compared Kisqali plus Femara to Femara alone as initial treatment of 668 postmenopausal women with ER+, HER2-Neg advanced breast cancer.3
Among patients with measurable disease, the overall response rate was 53% with Kisqali and Femara compared to only 37% with Femara alone. Kisqali was associated with a significant improvement in time to cancer progression and overall survival. The average duration of survival for the Kisqali-Femara combination was 64 months compared to only 51 months for Femara alone.
by Dr. C.H. Weaver M.D, Medical Advisor for Learn Look Locate. Copyright breastcancerconnect 2023.
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