Novartis Phase 3 Trial of Kisqali Shows Benefit in Early Breast Cancer

Novartis has announced positive topline results from an interim analysis of a Phase 3 trial evaluating Kisqali (ribociclib) plus endocrine therapy (ET) in patients with a form of early breast cancer (EBC) at risk of recurrence. Kisqali has already been approved in 99 countries worldwide, including by the FDA and the European Commission, for treatment. of advanced or metastatic breast cancer.

The Independent Data Monitoring Committee recommended stopping the trial early as the primary endpoint of invasive disease-free survival had 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. Per the study protocol, patient follow-up will continue to evaluate long-term outcomes, including overall survival.

“The positive topline results 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.”

More than 90% of patients diagnosed with breast cancer have EBC. Approximately 30-60% of people with HR+/HER2- stage II and III EBC treated with ET only remain at risk of breast cancer recurrence. The risk of recurrence peaks within the first three years after initial diagnosis and continues over decades. For many of these patients, there are currently no targeted therapeutic options outside of the standard chemotherapy and ET.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals. (Source: Novartis Website, 27 March, 2023)