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KISQALI (ribociclib). Prescribing Information.
Visceral metastases
Fictional patient
*Including AI and fulvestrant.1
†Pooled analysis of 1124 patients with visceral metastases (including liver metastases or ≥3 disease sites) from across the MONALEESA trials, 714 of these patients received 1L treatment and are included here (395 patients received KISQALI® + ET). These data are exploratory and hypothesis-generating only.1
‡HR 0.79; 95% CI: 0.65–0.97; p=0.023.1
1L, first-line; aBC, advanced breast cancer; AI, aromatase inhibitor; ALP, alkaline phosphatase; ALT, alanine transaminase; AST, aspartate aminotransferase;
CT, computerised tomography; ECOG, Eastern Cooperative Oncology Group; HER2-, human epidermal growth factor receptor 2 negative; HR+, hormone receptor positive; LFT, liver function test; mOS, median overall survival; PS, performance status; ULN, upper limit of normal.
References
Fit elderly
Fictional patient
Patients <65 years
Patients 65-74 years
Patients ≥75 years
*HR 0.69; 95% CI: 0.56–0.84.1
†HR 0.79; 95% CI: 0.58–1.07.1
‡HR 0.75; 95% CI: 0.46–1.21.1
1L, first-line; aBC, advanced breast cancer; AI, aromatase inhibitor; BC, breast cancer; chemo, chemotherapy; CI, confidence interval; CT, computerised tomography; ECOG, Eastern Cooperative Oncology Group; G-8, geriatric 8; ET, endocrine therapy; HER2-, human epidermal growth factor receptor 2 negative; HR, hazard ratio; mOS, median overall survival; OS, overall survival; PFS, progression-free survival; QoL, quality of life; PS, performance status.
References
AI-eligible postmenopausal
Fictional patient
*HR 0.76; 95% CI: 0.63–0.93; p=0.008.1
MONALEESA-2: N=668, double-blind, placebo-controlled, 1:1 randomised, multicentre, phase III trial in postmenopausal women with HR+/HER2- aBC. As 1L in advanced disease. No prior ET for aBC and no previous systemic chemotherapy for advanced disease. KISQALI® 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg continuous). The primary endpoint was locally assessed PFS, and the key secondary endpoint was OS. Other secondary endpoints included the ORR (complete or partial response), the CBR (overall response plus stable disease lasting 24 weeks or more), safety, and QoL assessments.1,2
References
Fulvestrant-eligible postmenopausal
Fictional patient
*This was an exploratory OS analysis with an extended follow-up of median 71 months.1
†HR 0.673; 95% CI: 0.504–0.899.1
**Early relapse or one prior ET for aBC.1
βResults from the 71-month analysis were not prespecified and were observational in nature, as such, there was no prespecified statistical procedure controlling for type 1 error.1 MONALEESA-3: N=726, double-blind, placebo-controlled, 2:1 randomised, phase III trial. As 1L and 2L in advanced disease plus those with early relapse in postmenopausal women with HR+/HER2– aBC. KISQALI® 600 mg or placebo orally once daily (3 weeks on/1 week off) + 500 mg intramuscular fulvestrant. The primary endpoint was locally assessed PFS. Secondary endpoints included OS, ORR, CBR, safety, and tolerability. 1L defined as: Newly diagnosed (de novo) aBC patients or patients with relapse >12 months from completion of neoadjuvant ET with no treatment for aBC or metastatic disease. 2L was defined as: Relapse on or within 12 months from completion of neoadjuvant ET with no treatment for advanced or metastatic disease (early relapse); relapse >12 months from completion of neoadjuvant therapy with subsequent progression after one line of ET for advanced or metastatic disease, and advanced or metastatic breast cancer at diagnosis that progressed after one line of ET for advanced disease with no prior neoadjuvant treatment for early disease.2
1L, first-line; aBC, advanced breast cancer; Ca, calcium; CA15-3, cancer antigen 15-3; CBC, complete blood count; CT, computerised tomography; ECOG, Eastern Cooperative Oncology Group; HER2-, human epidermal growth factor receptor 2 negative; HR+, hormone receptor positive; LFT, liver function test; PS, performance status.
References
Premenopausal
Fictional patient
*This was an exploratory OS analysis with an extended follow-up of median 54 months.1
†HR 0.80; 95% CI: 0.62–1.04.1
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 investigator-assessed 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.2
1L, first line; aBC, advanced breast cancer; AI, aromatase inhibitor; ALP, alkaline phosphatase; ALT, alanine transaminase; AST, aspartate aminotransferase; CBC, complete blood count; CT, computerised tomography; ECOG, Eastern Cooperative Oncology Group; Hb, hemoglobin; HER2-, human epidermal growth factor receptor 2 negative; HR+, hormone receptor positive; LFT, liver function test; PS, performance status
References
KISQALI® NSS - UAE
KISQALI® NSS - UAE