KISQALI + AI in Premenopausal Patients

KISQALI + AI in premenopausal patients

1L in premenopausal patients: KISQALI the first and only CDK4/6i to achieve 5-year mOS. ⁽¹⁾

MONALEESA-7: mOS at median 54-month follow-up: *⁽¹⁾

*Results from the 54-month analysis were not prespecified and were observational in nature, as such, there was no prespecified statistical procedure controlling for type 1 error. ^(1,2)
^† HR 0.80; 95% CI: 0.62–1.04. ⁽¹⁾

MONALEESA-7 study design

Portrait of a smiling asian premenopausal woman used for MONALEESA-7 breast cancer study design.

MONALEESA-7: N=672, double-blind, placebo-controlled, 1:1 randomised, phase III trial in pre- or perimenopausal women with HR+/HER2− ABC. As 1L in advanced disease and in patients who received 1 or fewer lines of chemotherapy for ABC. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg or anastrozole 1 mg) or tamoxifen* 20 mg orally once daily continuously + LHRH agonist (goserelin 3.6 mg subcutaneously on Day 1 of every cycle).

The primary endpoint was investigatorassessed PFS. The key secondary endpoint was OS, defined as the time from randomisation to death from any cause. ⁽¹⁾ * KISQALI should not be co-administered with tamoxifen. ⁽³⁾

Abbreviations

1L, first-line; ABC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4 and 6 inhibitor; CI, confidence interval; HER2–, human epidermal growth factor receptor 2 negative; HR, hazard ratio; HR+, hormone receptor positive; LHRH, luteinising hormone-releasing hormone; mOS, median overall survival, OS, overall survival; PFS, progression-free survival.

References

1. Lu Y-S, et al. Clin Cancer Res. 2022;28:851–859.
2. Im S-A, et al. N Engl J Med. 2019;381:307–316.
3. KISQALI (ribociclib), Summary of Product Characteristics.

Clinical Trial Information

MONALEESA-7 ClinicalTrials.gov number, NCT02278120

Study available online at: https://clinicaltrials.gov

Efficacy