Novartis Reports P-III Trial (NATALEE) Results of Kisqali (ribociclib) for the Treatment of Early Breast Cancer
- The P-III trial evaluating Kisqali + endocrine therapy (ET) vs ET alone in 5100 adult patients with HR+/HER2- early breast cancer who are at risk of recurrence across 20 countries. The study is being conducted in collaboration with TRIO & the therapy was developed by NIBR under a research collaboration with Astex Pharmaceuticals
- The company decided to stop the trial early as the 1EPs of iDFS have been met, following the IDMC recommendation & showed a reduction in risk of disease recurrence with consistent benefit in patients with stage II and stage III EBC regardless of nodal involvement
- The results will be presented at an upcoming medical meeting & submitted to regulatory authorities globally. The therapy was approved in 99 countries globally, incl. the US & EC
Ref: novartis | Image: novartis
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