Clinical Trial Results | mBC | KISQALI® (ribociclib)

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KISQALI + hormone therapy has been proven to help people like you live longer

People with HR+, HER2- metastatic breast cancer (mBC) were treated with KISQALI in multiple studies. In each study, the goal was to determine if KISQALI + hormone therapy could help people live longer than hormone therapy alone.

Leading cancer experts choose ribociclib (KISQALI^®)

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®), written by leading cancer experts, recommend ribociclib (KISQALI^®) + hormone therapy as effective and established treatment for eligible people with HR+, HER2- mBC.

With KISQALI + hormone therapy, half of all patients with HR+, HER2- mBC:

Lived nearly 2 years without their cancer getting worse and lived nearly 5 years after starting treatment.

KISQALI is not approved for use with tamoxifen.

Breaking down the data

In studies, time spent living without cancer getting worse is called progression-free survival, or PFS. The results are presented as median PFS, which is the length of time after starting the study that half of the patients were living without their cancer getting worse.

Results in postmenopausal women: KISQALI+ an aromatase inhibitor (AI), median PFS over 2 years*. KISQALI+ fulvestrant, median PFS nearly 2 years†. Results in premenopausal women: KISQALI+ an AI + goserelin, median PFS over 2 years‡

*In one study, median PFS at a 26-month check-in was 25.3 months with KISQALI + a type of hormone therapy called an AI vs 16.0 months with placebo + an AI.
^†In another study, median PFS at a 20-month check-in was 20.5 months with KISQALI + a type of hormone therapy called fulvestrant vs 12.8 months with placebo + fulvestrant.
^‡In a third study, median PFS at a 19-month check-in was 27.5 months with KISQALI + an AI + a type of hormone therapy called goserelin vs 13.8 months with placebo + an AI + goserelin.

Time spent living with breast cancer is called overall survival, or OS. The results are presented as median OS, which is the length of time after starting the study that half of the patients were still living.

Results in postmenopausal women: KISQALI+ an AI, median OS over 5 years§. KISQALI+ fulvestrant, median OS over 4 years‖. Results in premenopausal women: KISQALI+ an AI + goserelin, median OS nearly 5 years¶

^§In one study, median OS at an 80-month check-in was 63.9 months with KISQALI + an AI vs 51.4 months with placebo + an AI.
^||In another study, median OS at a 71-month check-in was 52.2 months with KISQALI + fulvestrant vs 41.5 months with placebo + fulvestrant. This 71‑month analysis was observational, and not preplanned to detect a false positive or show a difference between treatments.
^¶In a third study, median OS at a 54-month check-in was 58.7 months with KISQALI + an AI + goserelin vs 47.7 months with placebo + an AI + goserelin. This 54‑month analysis was observational, and not preplanned to detect a false positive or show a difference between treatments.