(RTTNews) - Novartis (NVS) announced positive results from an interim analysis of NATALEE, a Phase III trial evaluating Kisqali (ribociclib) plus endocrine therapy (ET) in a broad population of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer at risk of recurrence.
The company noted that the Independent Data Monitoring Committee recommended stopping the trial early as the primary endpoint of invasive disease-free survival (iDFS) has been met.
According to the company, Kisqali plus endocrine therapy significantly reduced the risk of disease recurrence, compared to standard adjuvant endocrine therapy alone, with consistent benefit in patients with stage II and stage III EBC regardless of nodal involvement.
Approximately 5,100 adult patients with HR+/HER2- early breast cancer across 20 countries were randomized in the trial, including patients with tumor stages IIA (select patients), IIB or III, regardless of nodal involvement.
The company said NATALEE explored a lower starting dose (400 mg) of Kisqali than the dose approved for treatment in metastatic breast cancer (600 mg) with the goal to minimize disruptions to patient quality of life without compromising efficacy.
Kisqali was developed by the Novartis Institutes for BioMedical Research under a research collaboration with Astex Pharmaceuticals.
Kisqali has been approved in 99 countries worldwide, including by the United States Food and Drug Administration and the European Commission. In the U.S., Kisqali is approved for the treatment of adult patients with HR+/HER2- advanced or metastatic breast cancer in combination with an AI as initial endocrine therapy or fulvestrant as initial endocrine therapy or following disease progression on endocrine therapy in postmenopausal women or in men.
In the EU, Kisqali is approved for the treatment of women with HR+/HER2- advanced or metastatic breast cancer in combination with either an AI or fulvestrant as initial endocrine therapy or following disease progression. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone agonist.
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