How KISQALI Works
Find out how this combination treatment works.
Live Longer with KISQALI
The only treatment of its kind 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 >| See Premenopausal Results >
Results for Postmenopausal Women Taking KISQALI + an NSAI
In a clinical trial with 668 women, 334 were treated with KISQALI + a nonsteroidal aromatase inhibitor (NSAI) and 334 women were treated with 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 a clinical trial, KISQALI + an NSAI extended the length of time women were alive from the start of treatment—also called overall survival (OS). Median OS is the length of time when half of the women were still alive. Median OS 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 progression-free survival
In the same clinical trial at a 15-month check-in, 334 women taking KISQALI + an NSAI still showed no disease progression at 15 months vs 14.7 months for 344 women taking placebo + an NSAI. Median progression-free survival (PFS) is the length of time when half of the women had not yet progressed.
Results for Premenopausal Women Taking KISQALI + an NSAI + Goserelin
KISQALI was studied in a second clinical trial dedicated exclusively to younger women. In the clinical trial of 495 women, the median age was 44 years (range 25 to 58). In a subgroup analysis, 248 women were treated with KISQALI + a nonsteroidal aromatase inhibitor (NSAI) (ie letrozole or anastrozole) + goserelin, and 247 women were treated with an NSAI + goserelin. Progression-free survival (PFS) was the primary outcome measure of the clinical trials. Overall survival (OS) was a secondary end point.
Overall survival
In a second clinical trial, KISQALI + an NSAI + goserelin subgroup showed extended length of time women were alive from the start of treatment – also called overall survival (OS). Median OS is the length of time when half of the women were still alive. At a 54-month observational check-in, results showed the median OS was 58.7 months for KISQALI + an NSAI + goserelin vs 47.7 months for placebo + an NSAI + goserelin. This 54-month analysis was not pre-planned to detect a false positive or show a difference between treatments. KISQALI is not approved for use with tamoxifen. KISQALI may cause increased risk of heart rhythm problems (QT prolongation) when combined with tamoxifen.
Median progression-free survival
In the same clinical trial at 35-month check-in, half the women in the KISQALI + an NSAI + goserelin subgroup 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.
Results for Postmenopausal Women Taking KISQALI + Fulvestrant
In a third clinical trial with 726 women, 484 were treated with KISQALI + fulvestrant and 242 women were treated with fulvestrant alone. Progression-free survival (PFS) was the primary outcome measure of the clinical trials. Overall survival (OS) was a secondary end point.
Overall survival
In a third clinical trial with 726 women, 484 were treated with KISQALI + fulvestrant and 242 women were treated with placebo + fulvestrant. KISQALI + fulvestrant extended the length of time women were alive from the start of treatment – also called overall survival (OS). Median OS is the length of time when half of the women were still alive. 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 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 progression-free survival
In the same clinical trial at 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.
