For Healthcare Professionals Outside the US
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 luteinizing hormone‑releasing hormone (LHRH) agonist.

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Experts present data

Adding to the growing body of evidence for KISQALI

KISQALI demonstrated an overall survival advantage in a trial dedicated to first-line premenopausal patients^1,2

Updated overall survival results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2–negative advanced breast cancer treated with endocrine therapy ± ribociclib
Tripathy D, Im S-A, Colleoni M, et al.

Background and methods

Significant improvement in overall survival was previously demonstrated in an analysis with a median follow-up of 35 months, after which patients and investigators were unblinded, allowing patients with ongoing treatment in the placebo arm to cross over to the KISQALI arm
- OS at a median follow-up of 35 months (ITT population): Not reached with KISQALI + AI/tamoxifen vs 40.9 months in the placebo arm (HR=0.71; 95% CI: 0.54-0.95; P=0.00973)
Updated OS results from an ad hoc exploratory analysis of the MONALEESA-7 trial with a median follow-up of 54 months are presented below
- This 54-month analysis allows for an additional ~20 months of follow-up

Nearly 5 years median OS in premenopausal patients in combination with ET^1,2

KISQALI + ET
(n=248)
58.7 months
(95% CI: 50.3-NR)

vs

Placebo + ET
(n=247)
48.0 months
(95% CI: 42.5-52.6)

HR=0.76 (95% CI: 0.61-0.96)

Time to chemotherapy was delayed by over 4 years

ITT mTTC results: 50.9 months with KISQALI + AI/tamoxifen vs 36.8 months in the placebo arm (HR=0.69; 95% CI: 0.56-0.87)
AI mTTC results: 50.9 months with KISQALI + AI vs 36.0 months in the placebo arm (HR=0.66; 95% CI: 0.51-0.85)
- Time to chemotherapy was an exploratory end point and was defined as the time from randomization to the beginning of the first chemotherapy after discontinuing study treatment
- There was no prespecified statistical procedure controlling for type 1 error

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View significant OS data for KISQALI
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Predictive and prognostic value of aBC subtypes in patients treated with KISQALI³

Correlative biomarker analysis of intrinsic subtypes and efficacy across the MONALEESA phase III studies
Prat A, Chaudhury A, Solovieff N, et al.

Aleix Prat, MD, shares highlights

Background and methods

The largest of any retrospective and exploratory analysis for a CDK4/6 inhibitor to evaluate the correlation of aBC subtypes with efficacy outcomes
- HER2-enriched, luminal A and B, and basal- and normal-like subtypes were analyzed
Tumor samples from 1303 patients enrolled in the MONALEESA-2, MONALEESA-3, and MONALEESA-7 trials were analyzed using the PAM50 gene signature assay. 1160 samples were evaluated in this analysis
- The prognostic and/or predictive relationships of the PAM50-based subtypes with PFS as well as risk of tumor progression were evaluated

Results
Prognostic value of subtypes

Compared with luminal A—which is the most common subtype and has the best prognosis—the following subtypes had a higher risk of tumor progression in all patients
- Luminal B: ~1.4 times higher
- Normal-like: ~1.3 times higher
- HER2-enriched: ~2.3 times higher
- Basal-like: ~4 times higher

Consistent PFS results across the majority of aBC subtypes in patients treated with KISQALI + ET

consistent-pfs-results

KISQALI + ET demonstrated a significant PFS improvement in the majority of subtypes, including those with a worse prognosis

The HER2-enriched subtype derived the largest benefit with a 61% reduction in risk of progression or death with KISQALI
Patients with the basal-like subtype did not exhibit a benefit with KISQALI + ET. Only ~3% of patients across the MONALEESA trials had the basal-like subtype

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CompLEEment-1 analyses highlight important findings for KISQALI in a setting that reflects clinical practice^4-6

Overview

CompLEEment-1 is an ongoing phase IIIb trial to assess the safety and efficacy of KISQALI + letrozole in the first line setting for 3246 patients with HR+/HER2– aBC
The summaries below present findings from an expanded safety analysis and two subgroup analyses, reflecting the use of KISQALI in a broader and more diverse patient population likely to be seen in clinical practice

Learn more about CompLEEment-1

Safety profile manageable and consistent with the MONALEESA trials⁴

Ribociclib + letrozole in patients with hormone receptor-positive human epidermal growth factor receptor 2-negative advanced breast cancer: expanded safety analysis of the phase IIIb CompLEEment-1 trial
Lu J, Cottu P, Martín M, et al.

Summary

Expanded safety analysis of CompLEEment-1 provides information on dose modifications and treatment discontinuation due to AEs, as well as the clinical impact of adverse events of special interest (AESIs)
Dose modifications due to treatment-related AEs occurred in 68.9% of patients; 12.9% of patients discontinued treatment due to treatment-related AEs
AESIs were not fatal, rarely led to hospitalizations, and decreased over time
- Selected AESIs were neutropenia, increased ALT/AST, and QTcF interval prolongation

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Findings support the use of KISQALI + letrozole in patients with CNS metastases⁵

Ribociclib + letrozole in patients with hormone receptor-positive human epidermal growth factor receptor 2-negative advanced breast cancer and central nervous system metastases: subgroup analysis of the phase IIIb CompLEEment-1 trial
Cottu P, De Laurentiis M, Marchetti P, et al.

Summary

CNS metastases are common in aBC and are associated with a poor prognosis. Patients with CNS metastases are frequently excluded from clinical trials
51 patients in CompLEEment-1 had CNS metastases, providing insight into the efficacy and safety of KISQALI + letrozole in this population
- Median duration of exposure to KISQALI was 16.8 months
- Median time to progression was not reached (95% CI: 15.5-NR); event-free probability at 30 months was 56.1% (95% CI: 39.3-69.8)
- ORR in patients with measurable disease and CNS metastases at baseline (n=35): 42.9% (95% CI: 26.3-60.6) and clinical benefit rate was 62.9% (95% CI: 44.9-78.5)
Serious treatment-related AEs occurred in 3.9% (n=2) of patients; 7.8% (n=4) of patients discontinued treatment due to treatment-related AEs

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Outcomes in premenopausal patients were consistent with results from MONALEESA-7⁶

Ribociclib + letrozole in premenopausal patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial
Abdel-Razeq H, Cottu P, Ring A, et al.

Summary

722 premenopausal patients were included in this analysis. Median duration of exposure to KISQALI was 18.3 months
- Median time to progression was 25.1 months (95% CI: 22.1-NR)
- ORR in patients with measurable disease (n=458): 49.3% (95% CI: 44.7-54.0) and clinical benefit rate was 69.7% (95% CI: 65.2-73.8)

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aBC, advanced breast cancer; AE, adverse events; AI, aromatase inhibitor; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CDK, cyclin-dependent kinase; CI, confidence interval; CNS, central nervous system; ET, endocrine therapy; HR, hazard ratio; ITT, intent to treat; mTTC, median time to chemotherapy; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; QTcF, QT interval corrected by Fridericia's formula; TTC, time to chemotherapy.

References: 1. Tripathy D, Im S-A, Colleoni M, et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2–) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Presented at: San Antonio Breast Cancer Symposium; December 8-12, 2020; San Antonio, TX. Poster PD2-04. 2. Data on file. Novartis Pharma AG. 3. Prat A, Chaudhury A, Solovieff N, et al. Correlative biomarker analysis of intrinsic subtypes and efficacy across the MONALEESA phase III studies. Presented at: San Antonio Breast Cancer Symposium; December 8-12, 2020; San Antonio, TX. 4. Lu J, Cottu P, Martín M, et al. Ribociclib + letrozole in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer (ABC): expanded safety analysis of the phase IIIb CompLEEment-1 trial. Presented at: San Antonio Breast Cancer Symposium; December 8-12, 2020; San Antonio, TX. 5. Cottu P, De Laurentiis M, Marchetti P, et al. Ribociclib + letrozole in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2−) advanced breast cancer (ABC) and central nervous system metastases: subgroup analysis of the phase IIIb CompLEEment-1 trial. Presented at: San Antonio Breast Cancer Symposium; December 8-12, 2020; San Antonio, TX. 6. Abdel-Razeq H, Cottu P, Ring A, et al. Ribociclib + letrozole in premenopausal patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer (ABC): subgroup analysis of the phase IIIb CompLEEment-1 trial. Presented at: San Antonio Breast Cancer Symposium; December 8-12, 2020; San Antonio, TX.