Novartis ribociclib Phase III NATALEE trial meets primary endpoint at interim analysis

Novartis announced positive topline results from an interim analysis of NATALEE, a Phase III trial evaluating 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 (EBC) at risk of recurrence. The Independent Data Monitoring Committee recommended stopping the trial early as the primary endpoint of invasive disease-free survival (iDFS) has been met. Ribociclib 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. 

“While most patients are diagnosed and treated early with the aim to cure breast cancer, the risk of cancer returning, often as metastatic disease, peaks within three years after diagnosis, but never goes away completely,” said Dennis J. Slamon, MD, Director of Clinical/Translational Research, University of California, Los Angeles Jonsson Comprehensive Cancer Center and Chairman and Executive Director of Translational Research In Oncology (TRIO) and NATALEE trial lead investigator. “There is a critical need for new, well-tolerated options that keep patients cancer-free without disrupting quality of life. The NATALEE trial, where ribociclib was given for three years plus ET, was designed with these unmet needs in mind, and it is extremely encouraging that this study met its primary endpoint.” 

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 ribociclib 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 ribociclib to many more patients diagnosed with breast cancer.”

“The result of the NATALEE trial is a welcome development in the management of breast cancer, offering new hope for a longer life in a broad population of patients with stage II and III HR-positive/HER2-negative early breast cancer at risk of recurrence,” said Dr. Rosario V. Pitargue, President, Philippine Society of Medical Oncology (PSMO). 

“These findings build on the legacy of ribociclib in metastatic breast cancer (MBC). Ribociclib is the first and only CDK4/6 inhibitor so far to have shown both consistent and significant improvements in overall survival across 3 phase III trials,” said Mr. Joel Chong, Country President, Novartis Healthcare Philippines, Inc.

ADVT.