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 + NSAI + LHRH agonist is the only CDK4/6 inhibitor that offers statistically significant longer OS than placebo + NSAI + LHRH agonist for HR+/HER2− premenopausal aBC patients2–4
MONALEESA-7: N=672, 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) + 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).2,5 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 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.2,6
KISQALI is not recommended to be used in combination with tamoxifen.5
Median overall survival was extended with KISQALI + NSAI vs placebo + NSAI2
The only CDK4/6 inhibitor that offers statistically significant longer OS than placebo + NSAI +LHRH agonist for HR+/HER2− premenopausal aBC patients2–4
MONALEESA-7: Prespecified subgroup analysis (N=495) of OS with KISQALI + NSAI + LHRH agonist vs placebo + NSAI + LHRH agonist2
Adapted from Im S-A, et al. 2019.2
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).2
MONALEESA-7: OS in HR+/HER2− premenopausal aBC women in an exploratory analysis with a median follow-up of 54 months7
Adapted from Tripathy D, et al. 2020.7
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 goserelin6
|KISQALI arm||Placebo arm|
|Primary endpoint: progression-free survival6|
|KISQALI or placebo + NSAI
+ LHRH agonist subgroup (n=495)
|key secondary endpoint: overall survival2|
|Significantly increased in the KISQALI arm vs the placebo arm,
HR 0.71 (95% CI: 0.54–0.95), p=0.00973
* KISQALI is not recommended to be used in combination with tamoxifen.5
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.5
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 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.
- Im S-A, et al. N Engl J Med. 2019;381(4):307–316.
- Finn RS, et al. Breast Cancer Res Treat. 2020;183:419–428.
- Goetz MP, et al. J Clin Oncol. 2017;35(32):3638–3646.
- KISQALI (ribociclib). Summary of Product Characteristics.
- Tripathy D, et al. Lancet Oncol 2018;19(7):904–915.
- Tripathy D, et al. Poster PD2-04. Presented at San Antonio Breast Cancer Symposium, 8–12 December 2020; San Antonio, USA.