Young age is an independent factor associated with higher risk of relapse and death for women diagnosed with breast cancer1
HOW MUCH INVALUABLE TIME CAN YOU OFFER YOUR HR+/HER2– PREMENOPAUSAL aBC PATIENTS?
KISQALI + ET* is the only CDK4/6i to show statistically significant improvements in OS in three Phase III trials2–4
MONALEESA-7: N=672, Phase III, double-blind, placebo-controlled, 1:1 randomisation in premenopausal 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) + NSAI (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).3,5 The primary endpoint was investigator-assessed progression-free survival. The key secondary endpoint was overall survival, defined as the time from randomisation to death from any cause. The other secondary endpoints included: proportion of patients who achieved an objective response, clinical benefit, time to response, duration of response, time to definitive deterioration of ECOG performance status from baseline, time to 10% deterioration for EORTC QLQ-C30 and safety.3,5
*KISQALI is not recommended to be used in combination with tamoxifen.6
Median overall survival was extended with KISQALI + NSAI + LHRH agonist vs placebo + NSAI + LHRH agonist3
The only CDK4/6 inhibitor that offers a longer OS when combined with NSAI + LHRH agonist vs placebo + NSAI + LHRH agonist in a Phase III clinical trial of premenopausal women3
MONALEESA-7: Prespecified subgroup analysis (N=495) of OS with KISQALI + NSAI + LHRH agonist vs placebo + NSAI + LHRH agonist3
Adapted from Im S-A, et al. 2019.3
Estimated OS for KISQALI + NSAI + LHRH agonist at 42 months was 69.7% (95% CI: 61.3–76.7) (n=248) vs 43.0% in the placebo + NSAI + LHRH agonist group (95% CI: 25.9–59.0) (n=247).3
No statistical test was performed for the subgroup of patients receiving NSAI as the combination partner.3
MONALEESA-7: OS in HR+/HER2− premenopausal aBC patients in an exploratory analysis with a median follow-up of 54 months.7
Adapted from Lu Y-S, et al. 2022.7
These results come from exploratory OS analysis updates and are not pre-specified and are observational in nature; as such, there was no pre-specified statistical procedure controlling for type 1 error.
Results should be interpreted with caution due to the limitation of exploratory analysis.
The ITT population included all patients (n=672) randomised to KISQALI or placebo with either tamoxifen* or an NSAI, both with goserelin5
| KISQALI arm | Placebo arm | |||||
|---|---|---|---|---|---|---|
| Primary endpoint: progression-free survival5 | ||||||
| ITT population (n=672) |
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| KISQALI or placebo + NSAI + LHRH agonist subgroup (n=495) |
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| key secondary endpoint: overall survival3 | ||||||
| ITT population (n=672) |
Significantly increased in the KISQALI arm vs the placebo arm, HR 0.71 (95% CI: 0.54–0.95), p=0.00973 |
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*KISQALI is not recommended to be used in combination with tamoxifen.6
CONFIDENCE IN KISQALI
Learn about QoL outcomes
KISQALI 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.*6
*KISQALI is not recommended to be used in combination with tamoxifen6
1L, first line; aBC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6, cyclin-dependent kinase 4 and 6; CI, confidence interval; HR, hazard ratio; HR+/HER2−, hormone receptor-positive/human epidermal growth factor receptor 2-negative; ITT, intention-to-treat; LHRH, luteinising hormone-releasing hormone; mOS, median overall survival; NR, not reached; NSAI, non-steroidal aromatase inhibitor; OS, overall survival; PBO, placebo; QoL, quality of life; RIB, ribociclib.
- Azim Jr HA and Partridge AH. Breast Cancer Res. 2014;16:427.
- Hortobagyi GN, et al. N Engl J Med. 2022;386(10):942–950.
- Im SA, et al. N Engl J Med. 2019;381(4):307–316.
- Slamon DJ, et al. N Engl J Med. 2020;382(6):514–52.
- Tripathy D, et al. Lancet Oncol 2018;19(7):904–915.
- KISQALI (ribociclib). Summary of Product Characteristics.
- Lu Y-S, et al. Clin Cancer Res 2022;2(5):851–859.