Which patients with eBC are eligible for treatment with KISQALI?

KISQALI^® (ribociclib), in combination with an aromatase inhibitor (AI), is approved for all patients with stage II/III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (eBC) at high risk of recurrence, including those with node-negative (N0) disease. See below to explore patient eligibility for KISQALI.¹

KISQALI is the only CDK4/6 inhibitor proven and FDA approved for all stage II/III node-positive and high-risk node-negative disease

Trial eligibility in stage II/III HR+/HER2- early breast cancer (eBC). Patients were eligible for monarchE if they had N1 disease with G3 or tumor ≥5 cm or N2 or N3 disease. All patients with N0 disease with high-risk features or nodepositive disease were eligible for NATALEE. About 50% of patients with stage II/III HR+/ HER2- eBC have N0 disease with high-risk features or N1 disease with G1/G2 and tumor size <5 cm. KISQALI is the only FDA-approved CDK4/6 inhibitor for those patients.

This information is not intended to compare the efficacy or safety outcomes of the clinical trials or their treatments. No implication of superiority or inferiority is intended or should be inferred.

In NATALEE, 0.4% and 0.2% of patients had stage I disease in the KISQALI + NSAI and NSAI-alone arms, respectively. In monarchE, 0.1% of patients in the abemaciclib + ET arm had stage IA disease^4,5
NATALEE allowed ET for ≤1 year prior to randomization; monarchE allowed ET for ≤3 months prior to randomization^4,5

High genomic risk may be determined by any of the following test scores⁵:

Oncotype DX®: ≥26
Prosigna® PAM50: High risk
MammaPrint®: High risk
EndoPredict®: High risk

This information is intended for reference only. Novartis does not endorse the use of any specific test or tool to help determine risk of recurrence, and there may be additional tests or tools available.

The brand names above are the property of their respective trademark owners.

CDK, cyclin-dependent kinase; eBC, early breast cancer; ET, endocrine therapy; FDA, US Food and Drug Administration; G, grade; HER2-, human epidermal growth factor receptor 2-negative; HGR, high genomic risk; HR+, hormone receptor-positive; N, nodal status.

NATALEE—a uniquely inclusive phase III trial, so you can IDENTIFY & TREAT patients with confidence