Novartis presented the positive results of the NATALEE study, demonstrating the benefit of Kisqali (ribociclib) plus endocrine therapy in early HR+/HER2- breast cancer patients.
Kisqali reduced the risk of disease recurrence in HR+/HER2- breast cancer. The drug showed significant improvement in stage II and stage III early breast cancer regardless of nodal involvement.
The NATALEE study enrolled more than 5,000 patients with HR+/HER2-negative early breast cancer. Patients were either administered with Kisqali or placebo in combination with endocrine therapy. The primary endpoint was disease-free survival at 44 months. Furthermore, Novartis announced that it would continue the evaluation, including overall survival.
In addition, the recently published NCCN guidelines have recommended using Kisqali plus an aromatase inhibitor as a Category 1 preferred CDK4/6 inhibitor as first-line therapy in metastatic breast cancer patients.
Early breast cancer accounts for 90% of diagnosed breast cancer cases. Nearly 30-60% of patients with stage II and III early breast cancer are at risk of recurrence.
Kisqali is a CDK4/6 inhibitor that demonstrated improvement in overall survival in three Phase 3 trials.