Novartis says Kisqali Phase 3 NATALEE trial met primary endpoint at interim

Novartis today announced topline results from an interim analysis of NATALEE, a Phase III trial evaluating Kisqali plus endocrine therapy, or ET, in a broad population of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative early breast cancer at risk of recurrence. The Independent Data Monitoring Committee recommended stopping the trial early as the primary endpoint of invasive disease-free survival, or iDFS, has been met. Kisqali plus ET significantly reduced the risk of disease recurrence, compared to standard adjuvant ET alone, with consistent benefit in patients with stage II and stage III EBC regardless of nodal involvement. Per the NATALEE study protocol, patient follow-up will continue to evaluate long-term outcomes, including overall survival. "The positive topline results from NATALEE represent a major milestone in our ambition to expand the benefits of Kisqali to patients with earlier stages of breast cancer, building on the heritage of this effective treatment in HR+/HER2- metastatic breast cancer," said Shreeram Aradhye, M.D., President, Global Drug Development and Chief Medical Officer, Novartis. "These data have the potential to be paradigm-shifting for patients at risk of recurrence, including those with no nodal involvement, who have limited well-tolerated options to prevent recurrence. Our teams are working on submissions to health authorities around the world with the hope to bring Kisqali to many more patients diagnosed with breast cancer."