Novartis breakthrough therapy LEE011 plus letrozole demonstrates superior progression-free survival as first-line treatment for HR+/HER2- advanced breast cancer compared to a standard of care

Novartis breakthrough therapy LEE011 plus letrozole demonstrates superior progression-free survival as first-line treatment for HR+/HER2- advanced breast cancer compared to a standard of care. LEE011 (ribociclib) plus letrozole reduced the risk of progression or death by 44% over letrozole alone, significantly extending progression-free survival (PFS) across all patient subgroups -   Results showed that the combination significantly improved tumor shrinkage, as more than half of women with measurable disease saw their tumor size shrink by at least 30% -   Data presented today as late-breaker during the ESMO 2016 Presidential Symposium and published simultaneously in  The New England Journal of Medicine to be the basis of worldwide regulatory filings - Results from the pivotal Phase III MONALEESA-2 study show LEE011 (ribociclib) plus letrozole significantly extended progression-free survival (PFS) compared to a standard of care, letrozole, as a first-line treatment in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (median PFS, 95% CI (19.3 months - not reached) vs. 14.7 months (13.0 - 16.5 months); HR=0.556;  p=0. Novartis announced today that the data will be featured in the official press briefing at the European Society for Medical Oncology (ESMO) 2016 Congress and presented as a late-breaker during the Presidential Symposium at 16:30 CEST (Abstract LBA1_PR).