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Kisqali-Faslodex Combo Continues To Improve Overall Survival in Advanced-Stage, Hormone-Receptor-Positive Breast Cancer in Postmenopausal Women

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The targeted therapy Kisqali (chemical name: ribociclib) combined with the hormonal therapy Faslodex (chemical name: fulvestrant) continued to offer better overall survival than Faslodex alone for postmenopausal women diagnosed with advanced-stage, hormone-receptor-positive, HER2-negative breast cancer, according to the latest results from the MONALEESA-3 study.

The research was presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and published online on May 28, 2021, by the Journal of Clinical Oncology:

Overall survival is how long a person lives, whether or not the cancer grows or comes back.

Advanced-stage breast cancer is breast cancer that has spread to tissue near the breast or to parts of the body away from the breast, such as the bones or liver.

About Kisqali and Faslodex
About the MONALEESA-3 study
Results from the latest analysis
What this means for you

About Kisqali and Faslodex

Kisqali is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. A kinase is a type of protein in the body that helps control cell division. Kisqali — a pill taken by mouth — works by stopping cancer cells from dividing and growing.

Kisqali is used in combination with an aromatase inhibitor to treat advanced-stage or metastatic, hormone-receptor-positive, HER2-negative breast cancer that hasn’t been treated with hormonal therapy yet in premenopausal, perimenopausal, and postmenopausal women. Arimidex (chemical name: anastrozole), Aromasin (chemical name: exemestane), and Femara (chemical name: letrozole) are aromatase inhibitors. Premenopausal and perimenopausal women who take Kisqali also should be treated with a medicine to suppress ovarian function.

Kisqali also is used in combination with the hormonal therapy Faslodex to treat advanced-stage or metastatic, hormone-receptor-positive, HER2-negative breast cancer that hasn’t been treated with hormonal therapy yet or has grown while being treated with a different hormonal therapy in postmenopausal women.

Faslodex is an estrogen receptor downregulator. Faslodex — a liquid injected into a muscle usually once a month — sits in a breast cell’s estrogen receptor so the cell can’t receive estrogen’s signals to grow and multiply. Faslodex also reduces the number of estrogen receptors and changes the shape of breast cell estrogen receptors so they don’t work as well.

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About the MONALEESA-3 study

In the MONALEESA-3 (Mammary Oncology Assessment of LEE011’s [Ribociclib’s] Efficacy and Safety) study, the researchers randomly assigned 726 postmenopausal women diagnosed with advanced-stage, hormone-receptor-positive, HER2-negative breast cancer to one of two treatments in a 2:1 ratio:

  • 484 women received Kisqali plus Faslodex
  • 242 women received Faslodex plus placebo (a pill that looked just like Kisqali but contained no medicine)

Although men were eligible to enroll in the study, because of the quick recruitment time, no men ended up being part of the study.

The women had either never been treated for advanced-stage breast cancer or had been treated with just one type of hormonal therapy for advanced-stage disease.

MONALEESA-3 results presented at the European Society for Medical Oncology (ESMO) 2019 Congress after about 3.5 years of follow-up found that Kisqali and Faslodex offered better overall survival than Faslodex alone.

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Results from the latest analysis

The latest results from the MONALEESA-3 study came after about 4.5 years of follow-up.

The cut-off date for overall survival analysis was Oct. 30, 2020. At that time:

  • 68 women were still being treated with Kisqali and Faslodex
  • 21 women were still being treated with Faslodex alone

Overall survival was:

  • 53.7 months for women treated with Kisqali and Faslodex
  • 41.5 months for women treated with Faslodex alone

“This is an exploratory analysis with extended follow-up of just under 5 years,” said lead author Dennis Slamon, M.D., Ph.D., director of clinical/translational research at the UCLA Jonsson Comprehensive Cancer Center, during his presentation. “Again, we saw that the ribociclib/fulvestrant arm maintained its [overall survival] advantage in this postmenopausal population.”

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What this means for you

If you’re a postmenopausal woman diagnosed with advanced-stage, hormone-receptor-positive, HER2-negative breast cancer that hasn’t been treated with hormonal therapy yet or has grown while being treated with a different hormonal therapy medicine, this study shows that Kisqali continues to improve overall survival.

You may want to talk to your doctor about this study and ask if treatment with a regimen that includes a CDK4/6 inhibitor, such as Kisqali, Ibrance (chemical name: palbociclib), or Verzenio (chemical name: abemaciclib), may be an option for you and your unique situation.

Read more about CDK4/6 inhibitors.

To discuss treatment options with others who are being treated for advanced-stage disease, join the Breastcancer.org Discussion Board forum Stage IV and Metastatic Breast Cancer ONLY.

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Written by: Jamie DePolo, senior editor

Reviewed by: Brian Wojciechowski, M.D., medical adviser


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