How KISQALI Works
Find out how this combination treatment works.
Live Longer with KISQALI
Proven to extend lives in 3 large clinical trials
Proven survival results in HR+, HER2- mBC
KISQALI® (ribociclib) is approved for both pre- and postmenopausal women or in men with HR+, HER2- metastatic breast cancer (mBC). KISQALI has extended lives in multiple clinical trials when taken in combination with a nonsteroidal aromatase inhibitor or fulvestrant. Watch the video below to find out what it means to be a Thriver with mBC and why women are asking for KISQALI by name.
See Postmenopausal Results: KISQALI + an NSAI >
See Postmenopausal Results: KISQALI + fulvestrant >
See Premenopausal Results > | See Quality of Life Results >
Helping women live even longer
In a clinical trial with 668 women, 334 were treated with KISQALI® (ribociclib) + a nonsteroidal aromatase inhibitor (NSAI) and 334 women were treated with placebo + an NSAI. KISQALI + an NSAI helped women live longer and delayed disease progression for longer than placebo + an NSAI. Progression-free survival (PFS) was the primary outcome measure of the clinical trials. Overall survival (OS) was a secondary end point.
Median overall survival
In this clinical trial, KISQALI + an NSAI extended the length of time women were alive from the start of treatment—also called overall survival (OS). Median overall survival for KISQALI was not reached at the 26-month check-in. Placebo was reached at 33 months. At an 80-month check‑in, results showed the median OS was 63.9 months for KISQALI + an NSAI vs 51.4 months for placebo + an NSAI. Median OS is the length of time when half of the women were still alive.
Median progression-free survival
In the same clinical trial, more than half of the women taking KISQALI + an NSAI had no signs of disease progression at 15 months, meaning median PFS was not reached at this time point. Median PFS was 14.7 months for women taking placebo + an NSAI. At a 26-month check-in, half the women taking KISQALI + an NSAI still showed no disease progression at 25.3 months vs 16 months for women taking placebo + an NSAI. Median progression-free survival (PFS) is the length of time when half of the women had not yet progressed.
KISQALI is the only treatment of its kind with a clinical trial exclusively dedicated to younger women with mBC
In a second clinical trial of 495 women, the median age was 44 years (ranging 25 to 58). In a subgroup analysis, 248 women were treated with KISQALI + a nonsteroidal aromatase inhibitor (NSAI) (eg, letrozole or anastrozole) + goserelin, and 247 women were treated with an NSAI + goserelin. KISQALI + an NSAI + goserelin helped women live longer and delayed disease progression for longer than an NSAI + goserelin. Progression-free survival (PFS) was the primary outcome measure of the clinical trials. Overall survival (OS) was a secondary end point.
Median overall survival
In this clinical trial, KISQALI + an NSAI + goserelin subgroup extended the length of time women were alive from the start of treatment—also called overall survival (OS). At a 54-month observational check‑in, results showed the median overall survival (OS) was 58.7 months for KISQALI + NSAI + goserelin vs 47.7 months for NSAI + goserelin. This 54‑month analysis was not pre-planned to detect a false positive or show a difference between treatments. Median OS is the length of time when half of the women were still alive.
Median progression-free survival
In the same clinical trial at a 35-month check‑in, half the women taking KISQALI + an NSAI + goserelin still showed no disease progression after 27.5 months vs 13.8 months for women taking placebo + an NSAI + goserelin. Median progression‑free survival (PFS) is the length of time when half of the women had not yet progressed. KISQALI is not approved for use with tamoxifen. KISQALI may cause increased risk of heart rhythm problems (QT prolongation) when combined with tamoxifen.
Living longer is possible—and proven
In a third clinical trial with 726 women, 484 were treated with KISQALI® (ribociclib) + fulvestrant and 242 women were treated with placebo + fulvestrant. KISQALI + fulvestrant helped women live longer and delayed disease progression for longer than placebo + fulvestrant. Progression-free survival (PFS) was the primary outcome measure of the clinical trials. Overall survival (OS) was a secondary end point.
Median overall survival
In this clinical trial, KISQALI + fulvestrant showed extended length of time women were alive from the start of treatment — also called overall survival (OS). Median overall survival for KISQALI was not reached at the 39-month check-in. Placebo was reached at 40 months. At a 56-month observational check‑in, results showed the median overall survival (OS) was 53.7 months for KISQALI + fulvestrant vs 41.5 months for placebo + fulvestrant. This 56‑month analysis was not pre-planned to detect a false positive or show a difference between treatments. Median OS is the length of time when half of the women were still alive.
Median progression-free survival
Progression-free survival was also shown in the same clinical trial. At the 39-month check-in, half the women taking KISQALI + fulvestrant still showed no disease progression after 20.5 months vs 12.8 months for women taking placebo + fulvestrant. Median progression-free survival (PFS) is the length of time when half of the women had not yet progressed.
Quality of life
Being able to continue the life you love is important as well
Living longer with KISQALI is about not only extending life, but keeping it the life you know and love. It’s about being able to continue the activities, traditions, and daily routines that you enjoy. Whether that's Sunday dinners with the kids, or the job you love, quality of life is the comfort we all deserve. Quality of life was preserved longer in women taking KISQALI in the clinical trials. Quality of life was a secondary outcome measure of the trials. It was based on a 30-item questionnaire that looked into overall physical, emotional, and social well-being while taking KISQALI and the impact of symptoms on each.
At a 35-month check-in, time to worsening of at least 10% in quality of life score was significantly delayed with KISQALI + an NSAI + goserelin (median 34.2 months) vs NSAI + goserelin (median 23.3 months). This analysis was not pre-planned to detect a false positive.
At a 26-month check-in, median time to worsening of at least 10% in quality of life score was 27.7 months with KISQALI + an NSAI vs 27.6 months with placebo + an NSAI.
In another trial, at a 39-month check-in, median time to worsening of at least 10% in quality of life score was 35.9 months with KISQALI + fulvestrant vs 33.1 months with placebo + fulvestrant. These analyses were not pre-planned to detect a false positive.
