Kisqali can extend survival and the amount of time you live without HR+/HER2- advanced or metastatic breast cancer getting worse, as part of a combination treatment regimen. In pre- and postmenopausal women, Kisqali has lengthened survival by about one year compared to other treatments, with an overall survival benefit of about 5 years.

In addition, across all three Phase 3 studies, quality of life for the patient was preserved or improved during treatment with Kisqali. This allows you to continue to enjoy the things that are part of your daily routine.

Studies have also shown that Kisqali can significantly reduced the risk of breast cancer recurrence in people with HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative (N0) disease. The effect on overall survival (OS) in this patient group is currently being studied.

Approved Uses for Kisqali

Kisqali (ribociclib) is an oral prescription medicine used to treat adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. It is used:

• in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.
• for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer (mBC) in combination with an aromatase inhibitor as initial endocrine-based therapy; OR in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.

Kisqali, from Novartis Pharmaceuticals, is in a drug class called CDK4/6 inhibitors. It works by blocking two proteins that help cancer cells grow and divide.

Related: How do you take Kisqali?

Can Kisqali lengthen the amount of time I can live?

Multiple studies have shown that Kisqali may help you live longer and live without your breast cancer getting worse. The following studies describe how this was determined.

First, it’s important to understand some terms used in the studies:

• Overall survival (OS) is defined as the total time you live with metastatic breast cancer (mBC). Lengthening OS can add more days to a person’s life.
• Progression free survival (PFS) is the amount of time your cancer does not grow or spread while taking treatment. PFS puts a hold on cancer growth.

1. MONALEESA-2 trial

The Phase 3 MONALEESA-2 trial study enrolled 668 postmenopausal women with HR-positive, HER2-negative mBC for initial endocrine-based therapy.

In this study, Kisqali (ribociclib) plus an aromatase inhibitor (letrozole) was compared to treatment with a placebo (an inactive agent) plus letrozole. These women had received no prior therapy for advanced disease.

Participants had a median age of 62 years (ranging 23 to 91 years) and 45% of patients were older than 65.

Patients were split into 2 groups and received either:

• letrozole orally once daily for 28 days + Kisqali orally once daily for 21 days (followed by 7 days off)
• letrozole orally once daily for 28 days + placebo orally once daily for 21 days (followed by 7 days off)
• Medications were given until the cancer progressed or there was unacceptable toxicity (side effects) to treatment.

Letrozole (brand name: Femara) is an aromatase inhibitor oral treatment that lowers estrogen levels in women and is used to treat certain types of breast cancer that need estrogen to grow.

Median Progression Free Survival

The main outcome investigators were looking at was progression free survival (PFS). PFS is defined as the amount of time cancer did not grow or spread while taking treatment. “Median” progression-free survival (PFS) is the length of time when half of the women had not yet had disease progression.

• In the Kisqali + letrozole group more than half of the women had no signs of disease progression (the median PFS not yet met) at 15 months of treatment. Median PFS was 14.7 months for women taking a placebo + letrozole.
• At the 26 month review, half the women taking Kisqali + letrozole showed no disease progression at 25.3 months, compared to 16 months for women taking placebo + letrozole.

Median Overall Survival

Investigators also looked at a secondary endpoint called overall survival (OS), which is the total amount of time participants lived with mBC. “Median” OS is the length of time when half of the women in each group were still alive.

• In the Kisqali + letrozole group, more than half of the women were still alive at 26 months of treatment, meaning the median overall survival (OS) had not yet been met. For the women taking a placebo + letrozole, the median OS was 33 months (meaning half lived longer than 33 months and half lived less than 33 months).
• At 80 months after treatment started, the median OS was 63.9 months (almost 5 years and 3.9 months) in the group receiving Kisqali + letrozole compared to 51.4 months (4 years and 3.4 months) in those receiving a placebo + letrozole.

Related questions

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2. MONALEESA-7

The MONALEESA-7 study was a Phase 3 study that enrolled younger patients with HR-positive, HER2-negative advanced or metastatic breast cancer for initial endocrine-based therapy. Participants were premenopausal or going through menopause (pre / perimenopausal) with a median age of 44 years (ranging from 25 to 58 years).

In a subgroup analysis of 495 women, 248 women were treated with Kisqali + an aromatase inhibitor (eg, letrozole or anastrozole) + goserelin, and 247 women were treated with a placebo plus an aromatase inhibitor + goserelin.

The primary outcome measure was progression free survival, and overall survival was a secondary endpoint.

Participants had received no prior therapy for advanced disease. Medications were given until the cancer progressed or there was unacceptable toxicity to treatment.

Median Progression Free Survival

• In the group that received Kisqali plus an aromatase inhibitor and goserelin, median progression free survival was over 2 years (27.5 months).
• In the group that received a placebo plus an aromatase inhibitor and goserelin, median progression free survival was just over one year (13.8 months).

Median Overall Survival

• In the group that received Kisqali plus an aromatase inhibitor and goserelin, median overall survival was 58.7 months (4 years and 11 months).
• In the group that received a placebo plus an aromatase inhibitor and goserelin, median overall survival, a secondary endpoint, was 47.7 months (almost 4 years).

Kisqali is not approved for use with tamoxifen, as the combination may cause an increased risk of heart rhythm problems (QT prolongation).

3. MONALEESA-3 trial

The MONALEESA-3 study enrolled 726 postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer for initial endocrine-based therapy, or after disease progression on endocrine therapy. Participants had a median age of 63 years (ranging from 31 to 89 years).

In a subgroup of this study, 484 participants were treated with Kisqali + fulvestrant and 242 women were treated with placebo + fulvestrant. Progression-free survival (PFS) was the primary outcome measure of the clinical trials. Overall survival (OS) was a secondary end point.

Fulvestrant (brand name: Faslodex) is an estrogen receptor antagonist injection used for treatment of some forms of advanced or metastatic breast cancer.

Median Progression Free Survival

• In the group that received Kisqali + fulvestrant, median progression free survival was 20.5 months.
• In the group that received placebo + fulvestrant, median progression free survival was 12.8 months.

Median Overall Survival

• In the group that received Kisqali plus fulvestrant, the median overall survival was 53.7 months (almost 4.5 years).
• In the group that received placebo plus fulvestrant, the median overall survival was 41.5 months (almost 3.5 years).

4. NATALEE trial in early breast cancer

The Phase 3 NATALEE trial showed that Kisqali significantly reduced risk of breast cancer recurrence by 25.1% (HR=0.749; 95% CI: 0.628, 0.892; P=0.0006) in people with HR+/HER2- stage II and III early breast cancer (EBC) treated with adjuvant Kisqali plus endocrine therapy (ET) compared to ET alone. This included people with high-risk node-negative (N0) disease.

The invasive disease-free survival (iDFS) benefit was consistently observed across all patient subgroups.

Follow-up results presented in 2024 showed a benefit beyond the 3 years of treatment and reduced the risk of recurrence by 28.5% (HR=0.715; CI 95% 0.609–0.840; P<0.0001), compared to ET alone, in patients with stage II and III HR+/HER2- EBC. Novartis will continue evaluating these study patients for longer-term outcomes, including overall survival.

In early breast cancer treatment, Kisqali is taken with or without food as a once-daily oral dose of 400 mg (two 200 mg tablets) for three weeks, followed by one week off treatment, in combination with four weeks of any aromatase inhibitor (AI). Patients should take Kisqali for 3 years.

Learn More: Kisqali side effects and warnings

Bottom Line

Kisqali, when used as part of treatment regimen for advanced or metastatic breast cancer, can lengthen the amount of you live (overall survival). Kisqali can also lengthen the amount of time your cancer does not grow or spread while taking treatment, called progression-free survival (PFS).

In addition, across all three Phase 3 studies, quality of life has been preserved or improved so you can continue to enjoy the things that are part of your daily routine.

Kisqali (ribociclib) is an oral prescription medicine used in adults to treat HR+, HER2- breast cancer that has gotten worse or has spread to other parts of the body (metastatic), in combination with other treatments.

This is not all the information you need to know about Kisqali (ribociclib) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this medicine and any questions you have with your doctor or other health care provider.

References

• Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med. 2022 Mar 10;386(10):942-950. doi: 10.1056/NEJMoa2114663. 
• Tripathy D, Im SA, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018 Jul;19(7):904-915. doi: 10.1016/S1470-2045(18)30292-4. Epub 2018 May 24. 
• Slamon DJ, Neven P, Chia S, et al. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol. 2021 Aug;32(8):1015-1024. doi: 10.1016/j.annonc.2021.05.353. Epub 2021 Jun 5. Erratum in: Ann Oncol. 2021 Oct;32(10):1307. 
• Kisqali (ribociclib) [product information]. Novartis Pharmaceuticals Corporation
  East Hanover, N.J. Revised 9/2024. Accessed Nov 6, 2024 at https://www.novartis.com/us-en/sites/novartis_us/files/kisqali.pdf
• FDA Approves Kisqali (ribociclib) for HR+/HER2- Metastatic Breast Cancer. Drugs.com. Accessed Sep 25, 2023 at https://www.drugs.com/newdrugs/fda-approves-kisqali-ribociclib-hr-her2-metastatic-breast-cancer-4496.html
• Kisqali.com. Novartis. Efficacy across trials. Accessed Sep 25, 2023 at https://www.hcp.novartis.com/products/kisqali/metastatic-breast-cancer/efficacy/across-trials/
• Kisqali.com. Novartis. Overall survival results. Accessed Sep 25, 2023 at https://www.us.kisqali.com/metastatic-breast-cancer/about-kisqali/overall-survival-results/#onco-image-block-145828
• FDA Approves Kisqali to Reduce Risk of Recurrence in People with HR+/HER2- Early Breast Cancer. September 17, 2024. Drugs.com. Accessed Nov 6, 2024 https://www.drugs.com/newdrugs/fda-approves-kisqali-reduce-risk-recurrence-hr-her2-early-breast-cancer-6369.html

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