NATALEE Trial | eBC | KISQALI® (ribociclib)

KISQALI—studied in a uniquely inclusive phase III trial

NATALEE was a positive study of KISQALI efficacy and safety in the broadest range of patients at risk of recurrence, including those with no nodal involvement.

STUDY DESIGN

NATALEE was a randomized, multicenter, open-label, phase III clinical trial of KISQALI + AI vs AI alone for the adjuvant treatment of HR+/HER2- eBC

Study population in NATALEE (N=5101): pre- and postmenopausal women and men with anatomic stage II or III HR+/HER2- eBC, including high-risk node-negative or node-positive disease (N0: T2 [G2 + high genomic risk or Ki-67 ≥20% or G3], T3, T4; All N1; All N2; All N3). 1:1 randomization. Study treatment was given for 3 years: KISQALI 400 mg/day (3 weeks on/1 week off) with an AI* (n=2549) vs AI alone* (n=2552); the AI was continued for 5 years. The long-term follow-up is up to ~91 months.

*Men and premenopausal women also received goserelin.²

Select exclusion criteria³

Prior treatment with a CDK4/6 inhibitor
ECOG performance status ≥2
Major surgery, chemotherapy, or radiotherapy within 14 days prior to randomization
Treatment with tamoxifen, raloxifene, or AIs for reduction in risk of breast cancer and/or treatment for osteoporosis within the last 2 years

Key end points²

Primary:

Invasive disease-free survival (iDFS)

Secondary:

Distant disease-free survival (DDFS)
Health-related quality of life (HRQOL)
Overall survival (OS) (ongoing)

KEY END POINT DESCRIPTIONS

The NATALEE trial was designed to help patients start and stay on therapy—whether new to adjuvant therapy or already on ET

Patients were eligible for KISQALI even with up to 12 months of prior ET—the most inclusive ET eligibility window of any proven CDK4/6 inhibitor trial in eBC³

NATALEE is the only positive trial of a CDK4/6 inhibitor to allow endocrine-based therapy for up to 12 months prior to randomization, so patients who began ET within the last year may still be candidates for treatment with KISQALI

Adjuvant dosing studied with the goal of balancing efficacy and adherence³

The 400-mg starting dose and 3-year duration were chosen for the adjuvant setting with the goal of minimizing dose-dependent adverse reactions and adherence issues related to tolerability—with the least possible impact on efficacy

PATIENT POPULATION

KISQALI is approved for all patients with stage II/III high-risk node-negative or node-positive HR+/HER2- eBC

Patient populations in the NATALEE and monarchE trials³:

Chart with 4 columns: AJCC Anatomic Staging, TN (M0), NATALEE, and monarchE. The NATALEE column has checkmarks in all TNM categories within stage II and stage III, with criteria for T2N0: only if grade 3, or grade 2 with Ki-67 ≥20% or high genomic risk. The monarchE column lists Xs for T2N0 and T4N0, and checkmarks for the remaining TNM categories with criteria for T0N1 (only if grade 3), T1N1 (only if grade 3), T2N1 (only if grade 3), and T4N1 (only if tumor size ≥5 cm or grade 3).

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^2,6
NATALEE allowed ET for ≤12 months prior to randomization; monarchE allowed ET for ≤12 weeks prior to randomization^2,6

NATALEE — a uniquely inclusive phase 3 trial, so you can IDENTIFY and TREAT patients with confidence

KISQALI is proven to help the broadest range of patients with stage II/III HR+/HER2- eBC^3,7,8

Regardless of nodal status; tumor size; tumor grade; age (greater than or equal to 18 years); menopausal status; Consider KISQALI for your patients

Patients with stage IIA, T2N0 HR+/HER2- eBC must meet the following criteria to be eligible for treatment with KISQALI: grade 3, or grade 2 with Ki-67 ≥20% or high genomic risk.³

Explore the KISQALI patient profiles

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RISK OF RECURRENCE
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