MONALEESA-2 trial of Novartis' LEE011 (ribociclib) stopped early

Independent Data Monitoring Committee recommends stopping the trial early as it met the primary endpoint, significantly extending progression-free survival (PFS) compared to letrozole alone, at pre-planned interim analysis.

"We are excited that these results validate our belief that LEE011 in combination with letrozole can be a beneficial treatment option for women diagnosed with HR+/HER2- advanced breast cancer," said Alessandro Riva, Global Head, Oncology Development and Medical Affairs, Novartis Oncology. "Novartis is dedicated to continuing to discover and develop innovative targeted therapies that help improve and extend the lives of women living with this disease."

As part of the company's ongoing commitment to addressing the needs of patients living with advanced breast cancer, Novartis will be evaluating possible expanded access programs in some regions to help ensure women who may benefit from LEE011 have access to it.

The adverse events observed with LEE011 in combination with letrozole in MONALEESA-2 were generally consistent with their respective known adverse event profiles.

The MONALEESA-2 trial will continue to assess overall survival data. Detailed efficacy and safety data will be submitted for presentation at a major medical congress and Novartis will begin discussions with global health authorities about regulatory filings.