The late-stage trial evaluated patients with Stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC)
Novartis’ Kisqali shows positive results in phase 3 trial. (Credit: Novartis AG)
Novartis has announced that Kisqali (ribociclib) plus endocrine therapy (ET), compared to ET alone, reduced the risk of cancer recurrence by 25.2% in a broad population of patients with breast cancer in Phase 3 NATALEE trial.
The late-stage trial evaluated patients with Stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC).
According to Switzerland-based Novartis, Kisqali is the first and only CDK4/6 inhibitor that has shown a consistent, clinically meaningful benefit in breast cancer patients, regardless of disease stage, menopausal or nodal status.
As per the findings, Kisqali and ET also showed a consistent, clinically meaningful invasive disease-free survival (iDFS) benefit in important pre-specified subgroups.
Additionally, the data across all secondary efficacy endpoints were also consistent, including distant disease-free survival (DDFS) and recurrence-free survival (RFS), along with the trend for improved overall survival.
Furthermore, the safety profile of CDK4/6 inhibitor at 400 mg was favourable with low rates of adverse events and limited need for dose modifications when administered for up to three years.
Novartis chief medical officer and Global Drug Development president Shreeram Aradhye said: “The compelling data from NATALEE highlight the potential of Kisqali to reduce the risk of cancer recurrence in this at-risk population, including node-negative patients, while maintaining a favourable safety profile.
“These potentially practice-changing results reinforce the unique and well-established profile of Kisqali as a proven treatment in HR+/HER2- metastatic breast cancer.”
NATALEE is a global multi-centre, randomised, open-label trial to assess the efficacy and safety of Kisqali with ET versus ET alone in patients with HR+/HER2- EBC. It enrolled 5,101 adult patients in 20 countries.
According to Novartis, the primary endpoint of NATALEE is iDFS as defined by the Standardised Definitions for Efficacy End Points (STEEP) criteria.
The pharmaceutical company plans to submit the Phase 3 data to regulatory authorities in the US and Europe at the end of 2023.