Novartis' reveals Phase III data for ribociclib

Novartis AG (NYSE:NVS; SIX:NOVN) announced interim data from the Phase III MONALEESA-2 trial of ribociclib ( LEE011) as a first-line therapy for hormone receptor (HR)-positive, HER2-negative metastatic breast cancer, including response rates and survival data for the cyclin dependent kinase 4 ( CDK4) and CDK6 inhibitor. The data were presented Saturday at the European Society for Medical Oncology meeting and published concurrently in the New England Journal of Medicine.

Among MONALEESA-2 patients with measurable disease, ribociclib plus letrozole led to an ORR of 53% vs. 37% for letrozole plus placebo (p=0.00028). Data presented at the American Society of Clinical Oncology meeting in June showed that approved CDK4/6 inhibitor Ibrance palbociclib from Pfizer Inc. (NYSE:PFE) plus letrozole led to an ORR of 55% vs. 44% for letrozole alone plus placebo (p=0.013) in the same population as of a Feb. 26 cutoff in the 666-patient Phase III PALOMA-2 study. ...