Successful Phase III MONALEESA-2 trial for LEE 011 (ribociclib), + letrozole for advanced breast cancer.-Novartis

Novartis announced that the MONALEESA-2 independent Data Monitoring Committee recommended stopping the trial early as results of a pre-planned interim analysis showed the trial met the primary endpoint of clinically meaningful improvement in PFS. MONALEESA-2 is a pivotal Phase III trial of LEE 011 (ribociclib), a cyclin dependent kinase inhibitor (CDK4/6), in combination with letrozole, compared to letrozole alone in postmenopausal women who had received no prior therapy for their hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.

The adverse events observed with LEE 011 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.

Comment: Competitors are Ibrance (palbociclib) from Pfizer which was approved in February 2015 by the FDA for advanced breast cancer and LY 2835219 from Eli Lilly in Phase III development.