Indications:1,2
- KISQALI® (ribociclib) is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy
- In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist
KISQALI is not recommended to be used in combination with tamoxifen.
For a woman diagnosed with advanced breast cancer (aBC), time matters.
The majority of oncologists and women surveyed report that overall survival (OS) is the #1 treatment goal of newly diagnosed patients with HR+/HER2– aBC.3,4
KISQALI + ET* is the only CDK4/6i that has demonstrated statistically significant OS benefit in HR+/HER– aBC across three Phase III trials:5–7
MONALEESA-2
Primary endpoint PFS: In the primary and updated analyses, PFS was significantly longer with KISQALI + letrozole than with placebo + letrozole (median in updated analysis: 25.3 months vs 16.0 months; HR for disease progression or death 0.57 [95% CI: 0.46–0.70]; p<0.001).8
In MONALEESA-2, KISQALI + letrozole demonstrated a statistically significant mOS benefit of
MONALEESA-3
Primary endpoint PFS: KISQALI + fulvestrant showed a significant benefit in PFS versus placebo + fulvestrant with an mPFS of 20.5 versus 12.8 (HR 0.59 [95% CI: 0.48–0.73]; p<0.001).9
In MONALEESA-3, KISQALI + fulvestrant demonstrated an mOS benefit of
MONALEESA-7
Primary endpoint PFS: KISQALI + ET* was associated with significant improvement in PFS versus placebo + ET, with a median of 23.8 months versus 13.0 months, respectively (HR 0.55 [95% CI: 0.44–0.69]; p<0.001).7
In MONALEESA-7, KISQALI + ET* demonstrated an mOS benefit of
versus placebo + letrozole in postmenopausal patients with HR+/HER2– aBC5
versus placebo + fulvestrant in postmenopausal patients with HR+/HER2– aBC6
versus placebo + ET in pre-/perimenopausal patients with HR+/HER2– aBC*5,7
Secondary endpoint:
At median follow-up of 6.6 years, mOS was 63.9 months (95% CI: 52.4–71.0) for KISQALI + letrozole and 51.4 months (95% CI: 47.2–59.7) for placebo + letrozole (hazard ratio=0.76 (HR 0.76 [95% CI: 0.63–0.93]; p=0.008)5
Exploratory endpoint:
At median follow-up of 56.3 months, mOS was 53.7 months (95% CI: 46.9–NR) for KISQALI + fulvestrant and 41.5 months (95% CI: 37.4–49.0) for placebo + fulvestrant (HR 0.73 [95% CI: 0.59–0.90]) (no p-value specified)6
Exploratory endpoint:
At median follow-up of 53.5 months, mOS was 58.7 months for KISQALI + ET* and 48.0 months for placebo + ET (HR 0.76 [95% CI: 0.61–0.96]) (no p-value specified)7
See below for MONALEESA-2, MONALEESA-3 and MONALEESA-7 study designs
Results are from individual studies. They are presented together for illustrative purposes only and should not be directly compared. Due to the exploratory nature of some of the analyses, the statistics are descriptive and need to be interpreted with caution.
Click the links below to find out more about OS results in patients treated with KISQALI + ET*:
Click to learn about the efficacy of KISQALI + ET* in postmenopausal patients with HR+/HER2– aBC
Click to learn about the efficacy of KISQALI + ET* in pre-/perimenopausal patients with HR+/HER2– aBC
Study designs
MONALEESA-2: Phase III trial of KISQALI + letrozole (n=334) vs placebo + letrozole (n=334) in postmenopausal patients with HR+/HER2– aBC. The primary endpoint was locally assessed PFS. In the primary and updated analyses, PFS was significantly longer with KISQALI + letrozole than with placebo + letrozole (median in updated analysis: 25.3 months vs 16.0 months; HR for disease progression or death 0.57 [95% CI: 0.46–0.70]; p<0.001).8
MONALEESA-3: Phase III trial of KISQALI + fulvestrant (n=484) vs placebo + fulvestrant (n=242) in postmenopausal patients with HR+/HER2– aBC who were treatment naive or had received up to 1 line of prior ET in the advanced setting. The primary endpoint was locally assessed PFS. KISQALI + fulvestrant showed a significant benefit in PFS versus placebo + fulvestrant with an mPFS of 20.5 versus 12.8 months (HR 0.59 [95% CI: 0.48–0.73]; p<0.001]). OS was a secondary endpoint.9
MONALEESA-7: Phase III trial of KISQALI + ET* (n=335) vs placebo + ET (n=337) in pre- and perimenopausal patients with HR+/HER2– aBC. The primary endpoint was investigator-assessed PFS. KISQALI was associated with a significant improvement in PFS, with a median of 23.8 vs 13.0 months with placebo (HR 0.55 [95% CI: 0.44–0.69]; p<0.001]). The key secondary endpoint was OS.7
*KISQALI is not recommended to be used in combination with tamoxifen.1,2
aBC, advanced breast cancer; CDK4/6, cyclin-dependent kinase 4 and 6; CI, confidence interval; ET, endocrine therapy; HER2−, human epidermal growth factor receptor-2 negative; HR, hazard ratio; HR+, hormone receptor-positive; LHRH, luteinising hormone-releasing hormone; mOS, median overall survival; NSAI, non-steroidal aromatase inhibitor; OS, overall survival; PFS, progression-free survival.
References
- KISQALI® (ribociclib) Great Britain Summary of Product Characteristics.
- KISQALI® (ribociclib) Northern Ireland Summary of Product Characteristics.
- Zanotti G, et al. BMC Cancer 2017;17(1):393.
- Pfizer Oncology. Meaningful goals in the management of mBC. Available at: https://www.breastcancervision.com/sites/default/files/section-pdf/mbc_g.... [Accessed April 2024].
- Hortobagyi GN et al. N Engl J Med 2022;386:942–950.
- Slamon DJ, et al. Ann Oncol 2021;32(8):1015–1024.
- Lu YS, et al. Clin Cancer Res 2022;28(5):851–859.
- Hortobagyi GN, et al. Ann Oncol 2018;29:1541–1547.
- Slamon DJ, et al. J Clin Oncol 2018;36(24):2465–2472.
